Liver Cancer News 2012
A Trio of Micro-RNAs Contributes to Liver Cancer Progression
29 Dec 2012
Researchers at the University of Southern California identified three micro-RNAs that reduce the expression of MAT1a, which results in smaller tumors in mice with HCC. The findings show that the three micro-RNAs are important regulators of HCC growth and could potentially serve as therapeutic targets in cancers associated with decreased MAT1a expression.
Baby Boomers with Liver Cancer Drive Demand for Liver Transplantation
7 Dec 2012
According to findings in the December issue of Liver Transplantation, a spike in liver transplantations due to hepatitis-C related liver disease occurs among Americans born between 1941 – 1960. Specifically, the highest HCV frequency occurred (in descending order) in those born 1951–55, 1956–60, 1946–50, 1941–45. These birth groups represent 81% of all new liver transplant registrants with HCV. Further evidence points to HCV as a primary risk factor for developing HCC in 47% of patients with HCC and between 2000 – 2010 there was a four-fold increase in new transplant candidates with HCV and HCC in this baby boomer group. The demand for transplants in this group may decrease over time, according to Dr. Scott Biggins, University of Colorado School of Medicine, because, “With the aging of the population of patients with HCV, many of these patients may not be healthy enough for transplantation and the number of liver transplants with HCV may decrease.”
Hepatocellular Carcinoma Risk May Be Reduced With Statins
1 Dec 2012
Researchers at the Mayo Clinic conducted a review that found a 37% drop in the development of HCC in patients that used statins versus nonusers. The association between statins and HCC risk was found both in Asian populations, who were 48% less likely to be diagnosed and Western populations who were 33% less likely to be diagnosed with the disease. The authors concluded that, “Randomized clinical trials in populations at high risk for HCC (especially in Asian populations with Hepatitis B) are warranted.”
Lutein May Prevent Hepatocellular Carcinoma
30 Nov 2012
Taking lutein supplements provides anticarcinogenic activity against chemicals-induced HCC in rats, according to E. R. Sindhu at College of Veterinary and Animal Sciences in Thrissur, Kerala, India. In the study, rats treated with lutein had lower levels of chemicals present in HCC-infected livers in additions to lower levels of cellular proliferation. “The protection provided by lutein against hepatocellular carcinoma may be a collective effect of its antioxidant activity and the inhibition of cytochrome P450 enzymes and inducing detoxifying enzymes,” according to researchers.
Aspirin May Reduce Risk of Liver Cancer, Death from Liver Disease
28 Nov 2012
In a decade-long study published by the Journal of the National Cancer Institute, it was found that aspirin and non-steroidal anti-inflammatory drugs (NSAIDS) may reduce the risk for liver problems. According to the study, people who took NSAIDS were 45% less likely to die from chronic liver disease and 41% less likely to be diagnosed with liver cancer than people who didn’t take NSAIDS. The study found an association between aspirin use and reduced risk of liver problems, but did not prove cause-and-effect.
Tivantinib Shows Modest Benefit in Relapsed Liver Cancer
26 Nov 2012
Results of a randomized, phase II trial of tivantinib, a c-MET inhibitor, showed modest but statistically significant slowing of time to progression of HCC in patients whose disease had advanced after first line therapy with Nexavar. Tivantinib showed no overall survival advantage over a placebo, but improvement was seen in a patient subgroup with a high expression of MET, an indicator of hepatocyte growth factor (HGF). Patients with low MET expression showed no significant slowing of time to progression or overall survival rate. Dr. Ivan Borbath of the Cliniques Universitaires Saint-Luc in Brussels said, “These are the first randomized data in HCC showing overall survival advantage with a MET inhibitor and identifying a biological subgroup responding to a targeted therapy.”
Liver Cancer Spikes among Spanish Coninfected with HIV, Hepatitis
26 Nov 2012
An analysis of records of HIV patients from 18 Spanish hospitals between 1999 – 2010 found that those with HCC were often diagnosed late had generally poor prognoses and that less than a third coinfected with hepatitis C ever received antiviral treatment. According to aidsmap, the researchers identified 82 cases of liver cancer in people with HIV, all of them among people coinfected with viral hepatitis. The scientists found a 14-fold increase in liver cancer between 2000 – 2009 and had four theories as to why: coinfected patients are living longer thanks to HIV therapies, giving liver cancer more time to develop; hepatitis C therapies do not work as well in HIV-positive people; HIV may speed the course of hepatitis-C related disease; improved clinical care for liver cirrhosis has also extended the lives of coinfected patients, giving cancer more time to develop. The authors called for vigilance by clinicians of coinfected patients and to perform routine ultrasound exams for the disease, even among those who have been cured of hepatitis C.
Smallpox Vaccine Kills Liver Cancer
23 Nov 2012
Bay Area doctors, leading a global team of scientists, are conducting a clinical trial that injects a re-engineered smallpox vaccine directly into liver cancer tumors. The scientists have tinkered with the vaccine so that it does not survive in the body and only grows in cancer cells. The scientists are cautiously optimistic because the smallpox vaccine is so effective at targeting and killing cancer cells and because of its decades-long safety record in immunizations. If successful, the therapy would be one of only two treatments available for HCC patients who have not responded to traditional chemotherapy and radiation and for whom surgery is not an option.
Chemo Bath Successful on Mesothelioma Patients and Liver Cancer Patients
19 Nov 2012
United Kingdom oncologists have reported success with the “chemo bath” treatment on two liver cancer patients. Chemosaturation with Percutaneous Hepatic Perfusion (CS-PHP) isolates the liver from the rest of the body, soaks it in chemo drugs for 60 minutes and then filters the blood almost completely before returning it to the body.
Hepatocellular Carcinoma Survival Rates Increased During 30-Year Period
16 Nov 2012
In a study of the National Cancer Institute’s Surveillance, Epidemiology and End Results between 1977 – 2006, researchers at the Detroit Medical Center found that overall survival rates for HCC increased in the U.S., but that incidence and mortality rose, as well. Neither 1 nor 5-year survival rates increased among patients under the age of 40, but patients older than 40 had significantly higher 5-year survival rates from 1997 – 2006. Differences in survival rates were poorest among African-Americans and best among non-white ethnic groups including Asians, Pacific Islanders and Native Americans. There were no significant differences in 5-year survival rates among men and women from 2002 – 2006, but African-American women had better 5-year survival rates than African-American men (18.3% vs. 8.3%). “The only thing that we lack here is what kind of treatments actually affect these outcomes, since the database does not carry all kinds of treatment modalities,” said Pardha Devaki, MD at Detroit Medical Center.
Israel Pioneers New Type of Liver Cancer Treatment
14 Nov 2012
A method new to Israeli HCC patients, irreversible electroporation applies a direct flow of high-voltage electrical to the malignant tumors. The method does not generate much heat or cold and can be used close to blood vessels without causing harm and takes just minutes under general anesthetic.
HBV Drugs Cut Risk of Cancer Recurrence
12 Nov 2012
In a retrospective study by Taiwanese researchers of 4,569 patients with HBV-related hepatocellular carcinoma who had curative surgery between 2003 – 2010, it was found that antiviral drugs appeared to lower a recurrence of HCC. Patients treated with entecavir (Baraclude), lamivudine (3TC) and telbivudine (Tyzeka) had a recurrence rate of 20.5% vs. 43.6% for patients who did not receive these drugs. The study has several strengths, including size and completeness, but according to Anna Lok, MD, University of Michigan at Ann Arbor, the findings “…are by no means definitive enough to answer the question of whether antiviral therapy after curative resection of HBV-related HCC will prevent disease recurrence.”
Background Liver Proliferation Linked to Non-Cirrhotic Patients with HCV
12 Nov 2012
The immunohistochemical stain Ki-67 could predict the risk for developing noncirrhotic HCC in patients with HCV. The increasing occurrence of HCC without cirrhosis and HBV as underlying causes is now recognized, especially in HCV-infected patients. Performing Ki-67 staining on liver biopsies, said Barry Schlansky, MD, Oregon Health Science University, Portland, may make it, “… possible to target surveillance for liver cancer in patients with HCV without cirrhosis based on increased proliferation in the background liver on biopsy.”
Antiviral Drug Cuts Cancer Risk in Hepatitis B
12 Nov 2012
Researchers at Toranomon Hospital in Tokyo found that chronic hepatitis B patients on long-term treatment with entecavir, a nucleoside analog reverse transcriptase inhibitor, had a significantly lower risk of getting liver cancer. In patients with cirrhosis, hepatocellular incidence in the entecavir-treated group was four times less than in the control group; patients without cirrhosis showed no significant improvement with the treatment. Older drugs in the same class, such as lamivudine, have been shown to reduce the incidence of HCC in chronic HBV patients, but resistance to it develops quickly in patients making long-term treatment difficult; entecavir has minimal resistance issues. Researchers believe entecavir is effective against HCC because it reduces HBV DNA in cells and that it reverses cirrhosis in the liver.
The Connection Between Fatty Liver Disease and the Increase in the Rate of Liver Cancer
10 Nov 2012
University of Missouri researchers studying patients that had non-alcoholic fatty liver disease (NAFLD) that led to HCC were surprised to discover that more than one-third of those patients did not have cirrhosis. HCC is on the rise in the U.S. and fatty liver disease is the third most common risk factor for HCC so determining that the more benign form of liver disease without cirrhosis is present in a great number of the population who will yet still develop one of the deadliest cancers is troubling to a country facing an obesity epidemic. “Physicians should be more aware that patients can develop primary liver cancer from NAFLD without cirrhosis. Surveillance for cancer is typically performed in the setting of cirrhosis. Thus, patients with NAFLD and without cirrhosis may need to be considered for periodic surveillance for HCC,” said Dr. Jamal Ibdah, M.D.
Prop Think: Mark the Calendar; Celsion to Release Thermodox Trial Results in January
9 Nov 2012
Results from the Phase III HEAT trial, which evaluates Thermodox in combination with radiofrequency ablation (RFA) as a primary treatment for hepatocellular carcinoma (HCC). The company believes it has achieved its primary endpoint of progression free survival in 380 patients and will have the data analyzed and ready for release early next year.
Tiny Catheter Zaps Liver Cancer
6 Nov 2012
Dr. Michael Itagaki, Interventional Radiologist at Queen’s Medical Center, Hawaii, uses an X-ray to guide a catheter through an artery feeding a liver tumor. He then injects very fine particles that emit radiation a distance of 2.5mm that delivers a high dose to the tumor without damaging surrounding tissue. Because the procedure is minimally invasive and done on an outpatient basis, it can be repeated as many times as necessary.
Concurrent Sorafenib and SBRT Too Toxic in Liver Cancer
5 Nov 2012
Sorafenib (Nexavar), a tyrosine kinase inhibitor, is the standard of care for locally advanced HCC; stereotactic body radiotherapy (SBRT) is a technique for precise, high-dose targeting of tissues from multiple angles and planes to deliver larger fractional doses of radiation over a shorter time span. A Phase I clinical trial combining both therapies against advanced liver cancer showed a 50% response rate for patients with smaller tumors and a 36% response rate for patients with larger tumors. Unfortunately, investigators found toxicity of the combined therapy was unacceptable for clinical use. “We found delivery concurrently of sorafenib and radiotherapy was challenging and likely limited by the volume of tumor and liver that’s irradiated, as well as drug dose,” said Dr. Brade, a radiation oncologist at the University of Toronto.
Thermedical Receives Medical Device Sales Clearance for New Tumor Treatment
1 Nov 2012
The U.S. FDA has approved the company’s tissue-ablation system, which uses needles or catheters to deliver radiofrequency waves (RF) to heat and kill soft tissue and small tumors. The new indication will help the company expand its medical device sales for laparoscopic and intraoperative surgical procedures. “Receiving FDA clearance is a significant milestone for Thermedical as it will facilitate our plans to carry out a series of clinical trials to evaluate the efficacy of our system for treating large, solid tumors, including liver cancer,” Dr. Michael G. Curley, president of Thermedical, noted.
Less Liver Cancer in HCV Patients Given Antiviral Therapy
25 Oct 2012
Danish researchers have found a possible correlation between HCV patients on antiviral treatment and a reduction of HCC risk. The researchers conducted a meta-analysis of trials where antiviral therapy lasted between 1 – 5 years and found a reduction in the risk of HCC with patients that responded to HCV antiviral treatment and even in those that did not respond. Lead author, Dr. Nina Kimer of Copenhagen University Hospital said that while, “Additional randomized trials with longer follow-up are still warranted … protection from HCC might be even better among patients in current antiviral therapy since the proportion of virological responders continues to increase with ongoing improvements in therapy.”
GenSpera Drug Compound Chosen for Phase II Carcinoma Trial
25 Oct 2012
The company has developed G-202, a plant-based cytotoxin that releases a cancer drug within a tumor. The Statewide Clinical Trials Network of Texas has selected G-202 for a Phase II clinical trial for patients with hepatocellular carcinoma.
Delcath Announces CE Marking for Hepatic CHEMOSAT ® Delivery System for Use with Doxorubicin Injection
22 Oct 2012
Doxorubicin is a globally established chemotherapeutic agent commonly used to treat hepatocellular carcinoma; CHEMOSAT® is a medical device that delivers doxorubicin via trans-arterial chemoembolization (TACE) to HCC tumors. The CE marking confirms that this device complies with the Essential Requirements of the Medical Device Directive and opens the regulatory pathway for countries in Asia that accept CE markings in their regulatory regime. The company does not expect to market CHEMOSAT® with doxorubicin injection in Europe at this time.
Common Liver Test Can Predict Liver Cancer Risk
19 Oct 2012
According to research published in the Journal of the National Cancer Institute, common liver function tests such as measurement of alanine transaminase (ALT) and aspartate transaminase (AST) levels, can be used to reliably predict HCC risk in the general population. Chi-Pang Wen, M.D. and colleagues at the National Health Research Institutes in Zhunan, Taiwan, used clinically available data on 130,000 patients with HCV and 298,000 without HCV to examine risk prediction models. “This simple tool for the general public more accurately assesses risk even among groups previously thought to be at low or average risk and may be helpful to educate and motivate individuals to pursue options beneficial in reducing their risk of liver cancer and all-cause mortality,” the authors write.
Lo Team Publishes Method for Whole-Genome Sequencing of Circulating Tumor DNA
17 Oct 2012
Chinese researchers have sequenced the entire genome of four hepatocellular carcinoma patients in the hopes of better understanding the progression of the disease. Other researchers have taken a targeted approach to sequencing cancer hotspots on the genome, but Dennis Lo, team leader from Chinese University of Hong Kong, says that being able to assess tumor heterogeneity is a key advantage of the whole-genome approach. As his team works to validate the method with a larger cohort of patients of different cancer types, the method could be used to,”… provide a genome-wide view of how a tumor evolves during the clinical course of a patient, , how the genomic aberrations evolve in tumors in response to treatment or during relapse or progression,” said Lo.
FDA OKs ArQule Phase 3 Liver Cancer Trial
16 Oct 2012
Based on the company’s positive results for the Phase II trial for tivantinib in the treatment of HCC, Phase III has been approved and is expected to begin by the end of this year or early in 2013. The trial will enroll about 300 previously treated patients with inoperable HCC in a randomized, double-blind study of tivantinib as a single agent therapy. “We are mindful of the high, unmet need among patients suffering from this disease, and we are proceeding with our partner, Daiichi Sankyo, toward the timely initiation of this trial,” said Paolo Pucci, chief executive office of ArQule in a statement.
Common Medical Screen Predicts Liver Cancer Risk in General Population
16 Oct 2012
Enzyme levels in blood are used to monitor liver function, but a team of scientists in Taiwan and the University of Texas MD Anderson Cancer Center has found that these enzymes can predict liver cancer risk, as well. Hepatitis B and C virus infection has long been an indicator of liver cancer risk; however, two enzymes predicted 91% of liver cancer cases, which outperformed HBV and HBC infection as risk predictors in the patients in this study. Said paper senior author Xifeng Wu, M.D., Ph.D., professor and chair of MD Anderson’s Department of Epidemiology, “If our research is confirmed in other studies, we’d have a measure for liver cancer risk that’s easy to apply via a simple blood test that’s already in widespread clinical use.”
Sirtex Brings Liver Cancer Therapy to Latin America
15 Oct 2012
Hospital Italiano de Buenos Aires is the first medical center in Latin America to offer the company’s Selective Internal Radiation Therapy (SIRT). Radioactive polymers one-third the diameter of a human hair are targeted directly to the tumor and deliver 40 times more radiation to the tumor than conventional radiation therapy. Sirtex had received approval from the National Administration of Drugs, Food and Medical Technology to administer SIR-Spheres to the 2000 Argentinians who will be diagnosed with liver cancer each year, with expansion to other hospitals in the country in the coming months.
Study: Cannabis Agonists Produce Anti-Cancer Effects in Human Liver Cancer Cells
12 Oct 2012
Researchers from the Tehran University of Medical Sciences have found that two synthetic cannabinoids, CB65 (CB2 receptor agonist) and ACEA (CB1 receptor agonist), have reduced malignant cell viability and cell invasion in a dose-dependent manner in treating HCC. The researchers concluded, “These data suggest that ACEA and CB65 are an option for novel treatment of hepatocellular carcinoma.”
New Study to Combat the Most Common Form of Liver Cancer
12 Oct 2012
Natural killer (NK) cells kill cancer in the body and stimulate other cells in the immune system to help attack cancer. Now, NK cells are primarily being used to treat cancers of the blood, but scientists at the University of Southampton believe these cells could be used to fight HCC. Researchers will chemically stimulate NK cells and antibodies in different ways to attack cancer cells. Salim Khakoo, Professor of Hepatology and Aymen Al-Shamkhani, Professor of Immunology and leaders of the study, say, “By trying different combinations of these chemicals and antibodies together, we will be able to develop an optimal method to use them for immunotherapy.” When a successful method for stimulating NK cells is found, the team will conduct test to find the best cancer-fighting effect.
New Treatment for Liver Cancer Patients at Al Ain Hospital
11 Oct 2012
Trans-Arterial Chemoembolisation (TACE) is a minimally invasive therapy where microspheres, coated with chemotherapeutic drugs, are injected into arteries feeding the tumors thereby blocking blood supply as well as delivering chemotherapy. TACE has been rated highly around the world as an effective treatment and now patients in the United Arab Emirates will have another tool to fight HCC.
Sorafenib Remains Standard Therapy for Advanced Hepatocellular Carcinoma
10 Oct 2012
The SEARCH trial treated 720 advanced HCC patients with either erlotinib and sorafenib or sorafenib and a placebo. The primary endpoint of the phase III randomised, double-blind trial was a 33% overall increase in survival of the erlotinib/sorafinib combined therapy; results were negative. Researchers recommend sorafenib alone to be the most effective, first line of treatment for hepatocellular carcinoma.
Lenvatinib Shows Potential in Advanced Liver Cancer
10 Oct 2012
Forty-six patients were enrolled in a Phase I/II trial to establish the efficacy and safety of lenvatinib in patients with advanced HCC. The drug is an orally active inhibitor of multiple receptor tyrosine kinases (RTKs) involved in angiogenesis and tumor proliferation. Researchers observed that 76% of patients required dose adjustments to manage toxicities, but found that median time to progression for HCC was 7.49 months and median overall survival was 13.9 months. Researchers concluded that lenvatinib might become a therapeutic option in the treatment of advanced hepatocellular carcinoma.
Building Hepatocellular Carcinoma Awareness: Dove Press Introduces a New Specialty Journal
10 Oct 2012
The Journal of Hepatocellular Carcinoma is an international, peer-reviewed, open access, online journal that will focus on hepatobiliary tumors. The Journal will publish on a wide range of topics, including new developments in the areas of epidemiology, vaccination, hepatitis therapy, pathology, molecular tumor classification and prognostication, new radiological techniques, new classes of targeted medical therapies, and the associated clinical trials and reports. According to Journal editor-in-chief, Professor Brian Carr, MD, FRCP, PhD, “This journal will provide a vehicle for publishing both new ideas and experimental work, as well as new insights and findings from clinical evaluation of the new drugs and new biology.”
Life Depends on the Liver
9 Oct 2012
The Hong Kong Liver Cancer Foundation surveyed 507 people above the age of 18 last August and found that the public had major misconceptions about liver cancer. Only 10% correctly identified the hepatitis B virus as the main cause of liver cancer in Hong Kong; 39% mistakenly thought that excessive alcohol consumption was the main cause of the disease; only 14% knew that liver cancer did not display any symptoms during its early stages, while 76% believed that symptoms, such as abdominal pain and yellowish skin and eyes are signs of the disease; and 96% underestimated or had no idea that those with the hepatitis B virus have a much higher risk of liver cancer than non-carriers. Medical experts think that 1 in 10 residents of Hong Kong carry the hepatitis B virus.
A Novel Oncogenic Network Specific to Liver Cancer Initiation
7 Oct 2012
A critical step in developing diagnosis, prevention and therapy for liver cancer is to identify targetable molecules and pathways responsible for cancer initiation. Using mouse models, researchers have discovered how AP-1, a gene regulator, modulates liver tumor cell death in the early stages of liver cancer. AP-1 controls the expression of the epigenetic modulator SIRT6 that represses Survivin, which is involved in programmed cell death. Any alteration of these proteins in mice during the initiation stage noticeably impaired liver cancer development in mice. “These results connect liver cancer initiation with epigenetics and cell death, and give new insights into why patients with metabolic diseases where SIRT6 is important, are at risk of developing liver cancer.”
Cleveland BioLabs: Cancer Drug Gets Orphan Status
2 Oct 2012
The company’s potential treatment for HCC, curaxin CBL0102, was granted the status by the U.S. Food and Drug Administration. Currently, CBL0102 is in a Phase I trial in Russia treating patients, “… with liver metastases of solid tumors of epithelial origin, or primary advanced hepatic carcinoma for which standard therapy has failed or doesn’t exist.”
Provectus Expands Protocol for Phase I Liver Cancer Study
27 Sep 2012
PV-10 is an oncology drug designed to selectively target and destroy cancer cells without harming surrounding healthy tissue. The study protocol will expand to include assessment of safety and efficacy in up to 24 more HCC patients as well as safety and efficacy in up to 12 HCC patients who are on a stable dose of sorafenib. In both cohorts, patients will receive PV-10 treatment of a single hepatic tumor, with more tumors treated based on positive response. Said Dr. Craig Dees, Ph.D., and CEO of Provectus, “… the major expansion of the program will allow us to better assess the potential of PV-10 both as a mono-therapy and in combination with standard systemic therapy so that we can complete design of crucial Phase 2 randomized control trials (RCTs).”
Bayer, Onyx and Astellas’ Phase III HCC Trial Fails to Meet Endpoints
25 Sep 2012
SEARCH, or Sorafenib and Erlotinib, a Randomized trial protocol for HCC patients, compared Nexavar in combination with Tarceva (Erlotinib) to Nexavar alone. Tarceva tablets did not improve overall survival for patients with unresectable hepatocellular carcinoma, but the trial did confirm the safety and efficacy of Nexavar in the treatment of HCC. Bayer and Onyx have jointly developed Nexavar; Tarceva is jointly marketed by Astellas and Genentech Pharmaceuticals.
Jennerex Phase 2 JX-594 Clinical Data for Hepatocellular Carcinoma Presented at IlCA Meeting
17 Sep 2012
The objective of the study was to determine the safety of JX-594, a targeted, oncolytic immunotherapy, followed by sorafenib in patients with advanced HCC. Secondary objectives included the effect of treatment on tumor response and disease control. David H. Kirn, M.D., founder, chief medical officer and president of R&D at Jennerex stated, “… JX-594 demonstrated its ability to selectively target and destroy tumors following intravenous infusion. This finding confirms the ability of JX-594 to target both primary and metastatic, or distant, tumors which we believe is important in this HCC population and most cancers.” The company has treated 160 patients to date with the treatment and is actively enrolling a multinational phase of the study.
Sirtex Deal Elevated with Liver Cancer Therapy: Real M&A
17 Sep 2012
The company’s SIR-Spheres, tiny radioactive beads that deliver directly to the liver a dose 40 times more powerful than typical radiation, is gaining supporters in the medical community. The treatment is seen by some oncologists as a last resort for dying patients because it is only used on 1% of eligible patients who have exhausted all other treatments and are willing to risk the higher radiation. Sirtex has been working to change that perception by conducting studies with more patients using SIR-Spheres in combination with first-line chemotherapy drugs like Nexavar. Studies like this, “… would revolutionize things,” said Peter Gibbs, medical oncologist at the Royal Melbourne Hospital. “It would take it (SIR-Spheres) from a marginal treatment that’s used occasionally to a mainstream treatment.”
Obesity Linked to Liver Cancer, Gallbladder Cancer
17 Sep 2012
An International Journal of Cancer study confirms a link between abdominal obesity and weight gain during adulthood and risk of liver cancer. The study found that men and women in the highest tertile of waist-to-hip and waist-to-height ratio were 2.5 times more likely to be diagnosed with liver cancer as those in the lowest tertile. In addition, men and women in the highest tertile of weight gain during adulthood had a 148% higher risk of liver cancer as compared to those in the lowest percentile.
Celsion Announces Independent Data Monitoring Committee Completes Last Intermediate Review of Phase III HEAT Study of Thermodox® in Primary Liver Cancer Prior to Final Data
14 Sep 2012
The HEAT study, a multinational, fully enrolled trial of Thermodox® in combination with radiofrequency ablation for HCC has completed a review of all 701 patients and the Data Monitoring Committee recommends the study continue to its conclusion. The goal of 380 patients with progression free survival (PFS) is projected to occur in the fourth quarter 2012. Celsion President and CEO, Michael H. Tardugno, said the company,”… is well prepared for the outcome of the HEAT study, with the regulatory, manufacturing, financial and commercial plans and resources in place to ensure success. We look forward to the next steps for Thermodox ®and remain confident in its potential to provide a new and important therapeutic option for patients with the disease.”
4SC in Talks with Three Potential Partners for Cancer Drug
13 Sep 2012
Liver cancer patients in a mid-stage clinical trial of 4SC’s Resminostat combined with Bayer AG’s Nexavar have survived for eight months; patients taking only Nexavar in a separate Bayer study survived 5.2 months. Based on this news, 4SC is looking for an investor to finance the last round of trials, to start mid-2013, in order to produce the safety and efficacy data needed for U.S. regulatory approval.
Magic Mushroom: AHCC Nutraceutical Used In Prostate Cancer Fight
5 Sep 2012
Active Hexose Correlated Compound (AHCC), a nutraceutical developed from different species of mushrooms in Japan, has been used to fight prostate cancer, but can also improve the prognosis for postoperative HCC patients. A nine-year study on AHCC, published in the Journal for Hepatology, the journal of the European Association for the study of the Liver, found that the compound enhances natural killer cell activity and could be a potent biological response modifier in the treatment of cancer patients.
Dr. Lorne Brandes: Preventing Liver Cancer by Blocking Inflammation
5 Sep 2012
The link between chronic inflammation and cancer has long been established, but in a paper recently published in Cancer Research, scientists may finally have an understanding of the mechanisms through which inflammation leads to cancer. When bacteria attack white cells, Triggering Receptor Expressed on Myeloid Cells (TREM-1) receptors send out signals that unleash inflammatory chemicals that help destroy the bacteria. This also causes tissue inflammation, which normally goes away with the disappearance of infection, but not when elevated TREM-1 levels persist.
According to team leader Dr. Anatolij Horuzsko at Georgia Health Science University: “We have long suspected that chronic inflammation is a very powerful tool in the initiation of cancer, and also in the progression or metastasis of cancer … One important triggering receptor for inflammation is TREM-1”. To test the hypothesis, a known carcinogen was injected into two groups of mice: One of normal controls and one that had been genetically engineered to remove the gene that makes TREM-1. Within 48 hours, livers in the control group mice showed signs of inflammation, injury and high levels of TREM-1, while the genetically modified mice remained healthy. “TREM-1 could be a target for any inflammation-associated cancer,” said Horuzsko.
New Research Sheds Light on the Molecular Mechanisms by Which a Virus Contributes to Cancer
29 Aug 2012
HCC is the third leading cause of cancer deaths worldwide and patients carrying the Hepatitis B virus are 100 times more likely to develop the cancer, but the reason why has been unknown until now. Researchers at the A*STAR Genome Institute of Singapore have studied liver cancer samples and adjacent non-cancerous tissue from 88 Chinese patients with HCC and identified 399 sites at which HBV was integrated into the genome. Researchers found that 40% of these breakpoints, sites at which the virus breaks before it is integrated into the genome of the host cell, occur within a region that may promote cancer formation. Non-cancerous tissues were also found to contain integrated viral genomes, but DNA from HCC tumors was found to contain more HBV integration sites.
Gene Protein Responsible for Liver Cancer Identified
23 Aug 2012
Researchers from Georgia Health Sciences University have discovered a gene that carries a protein, called TREM-1, which is associated with liver cancer. “We have long suspected that chronic inflammation is a very powerful tool in the initiation of cancer and also in the progression or metastasis of cancer,” said lead researcher Dr. Anatolij Horuzsko. TREM-1 is a triggering receptor for that inflammation and when laboratory mice are bred without the suspected cancer-causing gene TREM-1 was not present in those mice, which protected them from developing liver cancer. The team hopes these findings will lead to a TREM-1 related cancer treatment that could be applicable to other cancers, as well. “TREM-1 could be a target for any inflammation-associated cancer,” said Horuzsko.
American Liver Foundation Supports Centers for Disease Control Recommendation for Hepatitis C Testing of Baby Boomers
21 Aug 2012
According to the CDC, more than 2 million U.S. baby boomers are infected with hepatitis C, which accounts for 75% of all adults living with the virus in this country. Most of the 15,000 Americans who die from hepatitis C related disease are baby boomers and that number is expected to rise. The CDC estimates that 1 in 4 boomers have hepatitis C and that most of them are unaware which is why they are recommending that all U.S. citizens born from 1945-1965 have a one-time hepatitis C test. This test could identify more than 800,000 additional people with hepatitis C who, with newly available therapies, could cure 75% of infections and prevent the consequences of liver cancer and other HCV-related diseases. The American Liver Foundation strongly supports the CDC in this endeavor.
Multi-Cell Updates Results in Liver Cancer Tests
10 Aug 2012
Updated preclinical research results for MCT-465 and MCT-485, two of a family of the company’s prospective cancer therapeutics, showed cytotoxicity on several human hepatocellular carcinoma-cell lines. The company says these results warrant further study of the drugs to fight HCC, as well as other cancers. Xenogenics Corporation, a subsidiary of Multi-Cell, was granted a U.S. patent in 2005 for its Sybiol synthetic bio-liver device and in 2009, the company joined Maxim Biotech Inc. to research and develop products for studying liver stem cells and liver cancer.
Delcath Is About to Change the Way We Treat Liver Cancer
8 August 2012
The company’s proprietary system for chemosaturation delivers high dose chemotherapy agents to diseased organs or regions of the body while controlling systemic exposure to those agents. The company’s initial focus is on the treatment of primary and metastatic liver cancers and they are already marketing and selling the CHEMOSAT delivery system in Europe. The company is finalizing its New Drug Application with the FDA and expects approval of the treatment in the U.S. early next year.
Diabetics Have High Cancer Risk
4 Aug 2012
A population-based retrospective cohort study at Zhejiang University in Zhejiang, China found that type 2 diabetes mellitus was associated with a greater risk for liver cancer. The researchers found a 54% increased risk of liver cancer in male patients with type 2 diabetes mellitus. Factors affecting the associative risk of the two diseases include the mitogenic action of insulin, liver inflammation, hepatocyte damage and repair, diabetes-related diseases of the liver such as cirrhosis and steatosis and non-alcoholic fatty liver disease.
Bristol-Myers Reports Phase III BRISK-FL Trial Results
20 July 2012
The randomized, double-blind, multi-center study of brivanib conducted on patients with advanced HCC who had not received prior systemic treatment failed to meet its primary overall survival objective. Brian Daniels, Bristol-Myers Squibb global development and medical affairs senior vice president, said the company, “… remains committed to developing medicines for the treatment of diseases with serious unmet medical need, including diseases of the liver such as hepatitis C, hepatitis, B and liver cancer.” The company is considering its options for brivanib and will continue its ongoing trials of the drug with hepatocellular carcinoma patients.
Liver Failure, Cancer and Mortality in Cirrhotic Patients Coinfected with HIV/AIDS and HCV Predicted by Liver Stiffness
10 July 2012
Spanish researchers used a process called transient elastography (TE) on a study group of 239 HIV/HCV patients with a diagnosis of compensated cirrhosis to assess the predictive power of liver stiffness for liver cancer. Dr. Nicolas Merchante from Unidad de Enfermedades Infecciosas, Hosptital Universitario de Valme in Sevilla, Spain said: “Our findings indicate that liver stiffness predicts risks of liver failure and liver-related deaths in patients with compensated cirrhosis who are coninfected with HIV and HCV, providing more advanced detection of disease severity.” These findings also show that live stiffness can predict potential recovery and survival in patients with cirrhosis, adding to the prognosis for liver disease.
Scientists Develop Mouse Model That Could Lead to New Therapies for Liver Cancer
6 July 2012
Astrocyte elevated gene- 1 (AEG-1) is a cancer promoting gene found in hepatocellular carcinoma. Researchers at Virginia Commonwealth University have created a mouse model that demonstrates AEG-1 overexpression significantly accelerates the progression of liver cancer, plays a role in protecting liver cancer cells from chemotherapeutic drugs, and alters tumor angiogenesis. “This model moves us forward in the research process by allowing us to test a variety of compounds that could inhibit AEG-1 and prevent the development and progression of liver cancer,” said lead researcher Devanand Sarkar, M.B.B.S., PhD, Harrison Scholar at VCU Massey Cancer Center.
Antibody Gets High Marks in Small Hepatocellular Carcinoma Trial
6 July 2012
Tremelimumab, an antibody therapy directed at a T-cell antigen, achieved disease control in 75% of patients with HCC associated with hepatitis C infection. Two of seventeen patients had partial responses and 11 had stable disease during treatment; the entire cohort had median progression-free survival of 6.4 months and median overall survival of 7.5 months. At this time, Nexavar is the only treatment that can extend the life of patients with advanced HCC and with the disease being the second leading cause of cancer death worldwide, the results of this therapy are promising. “A disease control rate in excess of 75% and a time to progression longer than 4 months suggest that tremelimumab could be active against hepatocellular carcinoma,”, said Ignacio Melero, MD, PhD, a consultant oncologist at the Universidad de Navarra in Pamplona, Spain.
DKK1 Boosts Liver Cancer Diagnostic Options
2 July 2012
Measurement of the protein DKK1, overexpressed in HCC tissue, but not detectable in corresponding noncancerous liver tissue, could be used to diagnose hepatocellular carcinoma. AFP, currently the most widely used biomarker to diagnose HCC, has deficiencies, which include low sensitivity and an inability to distinguish HCC from chronic hepatitis in half of the cases. DKK1 alone or in combination with AFP was better able to distinguish between patients with or without HCC than AFP alone. In an accompanying commentary to the study from the University of Barcelona in Spain, researchers concluded there is “…still a long way to go before DKK1 can be accepted as a diagnostic tool,’ but, “… the study adds a new piece of the puzzle of HCC diagnosis and opens the door for further investigations of this promising tumor biomarker.”
Metformin May Reduce Liver Cancer Risk
21 June 2012
Metformin, a glucose-lowering drug used to fight diabetes, has been shown effective in reducing the incidence HCC according to a study conducted at the National Yang-Ming University in Taipei, Taiwan. Researchers found, “… in diabetic subjects, each incremental year increase in metformin use was associated with a nearly 7% reduction in the risk of developing HCC,” said Dr. Chun-Ying Wu on behalf of the study. While the mechanism that causes this decrease is unknown, one theory is that metformin may reduce insulin and glucose levels in the body, which may limit their effects on the formation and development of tumors in the body. Wu concluded, “By properly controlling glucose, metformin appears to help avoid or delay diabetes-associated complications, including liver cancer.”
Hepatitis B and Liver Cancer Among Asian Americans
21 June 2012
More than 8 out of 10 liver cancers in the United States are caused by hepatitis B or C virus, with a higher incidence of the disease among the American Asian community. According to the 2000 census, in San Francisco one in three people are of Asian descent and one in ten of those people are infected with hepatitis B; the American Vietnamese community has a liver cancer rate 11 times higher than whites, the highest in the nation. While the number of hepatitis infections is declining in the U.S., it may take years for fewer cases and better treatments to translate into fewer cancers, which is why outreach, education and vaccination against hepatitis B are being implemented in Asian communities around the country. UCSF physician and researcher Tung Nguyen, MD is a partner in the San Francisco Department of Public Health’s program to do just that: to make “San Francisco Hep B Free.”
Thermodox: Liver Cancer Treatment Is A “$1 Billion Drug,” Drugmaker Says
19 June 2012
The tiny company is making the most of its $70 million valuation by placing the very old cancer drug, doxorubicin, into a new delivery method and adding heat to fight HCC, which the World Health Organization has predicted will surpass lung cancer as the No. 1 cancer by 2020. Thermodox, intended for cancer patients not eligible for resection surgery, encapsulates doxorubicin in a liposome, which makes its way naturally into the liver after being introduced intravenously. Radiofrequency ablation is then applied directly to the cancerous lesion. Michael Tardugno, Celsion CEO, says that the use of this generic medicine administered once on an outpatient basis could prove to be a cost effective way to treat HCC at a time when health plans are scrutinizing the costs of new drugs closely. “We have the ability to take a very promising technology and apply it to an unmet medical need. Certainly this is a $1 billion drug,” said Tardugno.
Exelixis Reports Encouraging Data From Cabozantinib Cancer Drug Study
3 Jun 2012
Interim data from an ongoing phase 2 randomized trial involving 41 HCC patients treated with the drug showed median progression-free survival of 4.4 months and median overall survival of 15.1 months; HCC tumors regressed in 78% of patients. Cabozantinib provides coordinated inhibition of metastasis and angiogenesis to kill tumor cells while blocking their escape pathways. Said Dr. Michael Morrissey, CEO of Exelixis, “These interim data are encouraging and support the potential utility of cabozantinib in the treatment of HCC.”
Positive Phase 2 Study Results for Tivantinib in Previously Treated Hepatocellular Carcinoma to be Presented at ASCO
2 Jun 2012
The trial included 107 patients with unresectable HCC who had disease progression after first-line therapy or were unable to tolerate first-line therapy. Researchers found significant improvement in all areas: median overall survival on tivantinib was 7.2 months vs. 3.8 months on the placebo; median time to progression was 2.9 months on tivantinib vs. 1.5 months on the placebo; median progression-free survival was 2.4 months on tivantinib vs. 1.5 on the placebo. Adverse events were reported at similar rates in both arms of the study, with the exception of a higher incidence of fatigue, neutropenia and anemia in tivantinib-treated patients. “The data suggests that patients significantly benefited in time to progression and, importantly, those in a biologically relevant MET-high subgroup had an additional significant advantage in overall survival,” said Lorenza Rimassa, Deputy Director, Medical Oncology Unit, Humanitas Cancer Center, Milan, Italy. MET, a receptor tyrosine kinase present in healthy adults to support natural cellular function, plays multiple roles in human cancer when it is activated in cancer cells.
Liver Cancer Rates Continue to Rise, Vigilance Warranted
1 June 2012
Two researchers reported results from independent studies on the rise of HCC in the United States. The first, based on data gathered from the Surveillance Epidemiology and End Results (SEER) registry of the National Cancer Institute, found a three-fold increase in U.S. HCC rates from 1975 – 2007 with a 33% spike from 1998 – 2008. The second analysis, collected from data in the Nationwide Inpatient Sample, showed a significant jump in patients hospitalized with HCC in 2005. The greatest increase in HCC incidence occurred in people aged 50 – 59, which experienced a five-fold jump from 2.6 per 100,000 in 1975 – 1977 to 12.6 per 100,000 in 2005 – 2007; the highest rate was among Asians. Researchers from both studies attribute the causes of the HCC rise to hepatitis C viral infection among baby boomers and the rising prevalence of obesity and type 2 diabetes among the general population.
Whole Genome Sequencing Sheds Light on Hepatitis Virus Integration in the Cancer Genome
29 May 2012
The Asian Cancer Research Group (ACRG) has used whole genome sequencing to discover three novel genes associated with recurrent hepatitis B integration in hepatocellular carcinoma. The group, in collaboration with several universities in Singapore, took tumor samples from 88 Chinese HCC patients who underwent curative primary hepatectomy or liver transplant and found that HBV was found more frequently in tumors (86.4%) than in adjacent normal liver tissue (30.7%). The integration of HBV into a host genome is thought to be a major cause of HCC and is believed to cause chromosomal instability or alter expression and function of endogenous genes. The researchers also found that the recurrence of HBV was related to tumor size and other cancer markers. “Based on these results, we can better explore the detailed molecular mechanism and clinical impact of HBV integration, promoting the discovery and development of future liver cancer treatments,” said primary investigator of the project Hancheng Zheng.
UAB Study to Help Fight Liver Disease
26 May 2012
New guidelines drafted by the CDC propose that every American born from 1945 to 1965 be tested for the hepatitis C virus, a major cause of liver disease. This population includes 86 million people and Omar Massoud, UAB gastroenterologist, believes that the group includes at least 75% of all HCV infections in the nation because these baby boomers may have been exposed to blood transfusions before the U.S. blood supply was monitored for HCV contamination pre-1992. According to CDC estimates, a one-time test of all boomers could detect more than 800,000 additional people with HCV and, with two new FDA approved drugs that help cure 75% of HCV infections, more than 120,000 lives could be saved. The CDC selected UAB, Henry Ford Hospital in Detroit and Mount Sinai Medical Center in New York to run trials to test the effectiveness of the old guidelines for HCV. Massoud said results were worse than expected. In a second phase to test the new guidelines starting in July, UAB will check every boomer patient. Patients will have to give permission for the test, but since it will be free, Massoud expects nearly all patients will want the test since the possible consequences of untreated HCV are so dire. Said Massoud,” This may change the way that hepatitis C treatment is given.”
Sanofi To Test Cancer-Starving Compound in China in 2013
25 May 2012
Liver cancer patients with a high level of a protein called slit may have a new treatment. The slit protein nourishes the tumor and helps it spread to other parts of the body, but the Sanofi-Aventis compound, called slit-trap, blocks that protein. The company is working on a method of screening liver cancer patients who will best respond to the treatment. Half of the annual cases of liver cancers worldwide occur in China. The drugmaker is uncertain how effective the therapy may be, “But in China, even 10 percent of liver cancer patients would be an incredible number,” said Frank Jiang, Snofi-Aventis VP and head of R&D in the Asia Pacific.
Specialised Surgery a First for the Hastings
23 May 2012
Liver cancer patients who normally have had to travel great distances for surgery now have a state of the art facility in New South Wales, Australia. Dr. George Petrou at Port Macquarie Base Hospital has demonstrated that, “the laparoscopic approach for liver resection is safe and feasible for a patient with benign or malignant liver tumor.” Said Petrou, “Port Macquarie is now the definitive specialist liver cancer service in the North Coast Area Health Service.”
Mirna Therapeutics Presents Updates on Development Program for Lead Therapeutic Candidate
22 May 2012
The company has received exclusive license from Marina Biotech for a SMARTICLES (R) formulation used to deliver the miR-34 mimic to solid and hematological tumors. Micro RNAs are encoded in the human genome and are used as regulators of gene expression and are responsible for cellular growth and proliferation, among other duties. The SMARTICLES formulated miR-34 mimic has caused complete tumor regression in two different mouse models and toxicity levels have been safe with no immunostimulatory activity. “The exceptional therapeutic activity and favorable safety profile produced by our lead therapeutic candidate has us eager to transition into a clinical program where we can demonstrate proof of concept for the miRNA replacement therapy approach,” said Dr. Paul Lammers, President and CEO of Mirna Therapeutics. The Company expects to initiate a Phase I clinical trial within the next year.
Positive Phase 2 Clinical Data With Tivantinib in Hepatocellular Carcinoma
18 May 2012
ArQule, Inc. will make an oral presentation at ASCO on data with tivantinib as a single agent investigational second-line treatment in HCC. The randomized, double-blind study met its primary endpoint in January. “The robust statistical significance achieved in this trial reflects the anti-cancer activity of tivantinib alone and expands its therapeutic potential,” said Paolo Pucci, chief executive officer of ArQule.
Lilly To Present New Ramucirumab Data At ASCO 2012
18 May 2012
The company will present new, late-stage Phase III clinical trial data on the cancer therapy ramucirumab and its efficacy against hepatocellular carcinoma at ASCO June 1-5, Chicago, Illinois.
Data From Jennerex JX-594 Clinical Trials on Cancer To Be Presented at ASCO Annual Meeting
17 May 2012
Jennerex, Inc., a private clinical-stage biotherapeutics company focused on developing oncolytic products for cancer, will present two abstracts on the efficacy of their drug, JX-584 at ASCO, June 1-5 in Chicago, Illinois. The data will relate completed and ongoing clinical trials of the drug in the treatment of hepatocellular carcinoma.
Hepatitis C, Liver Cancer Research at UNC Secures $2.3M Federal Grant
17 May 2012
The links between liver cancer and Hepatitis C have been hard to study, but a five-year grant from the National Cancer Institute will enable two UNC researchers to combine their efforts to find that connection. Lishan Su, professor of microbiology, has developed a lab model that replicates how the disease progresses in humans, and Stanley Lemon, professor of biology and medicine, has been working to understand how genetic changes in HCV affect progression of HCC. Numerous studies have documented that inflammation has something to do with liver cancer, but Lemon sees the evidence pointing to something more that is happening. “We believe that the virus is interacting specifically with host cell tumor suppressor pathways to promote cancer, and we want to understand what drives this progression from infection to cancer in order to figure out how to stop it,” said Lemon.
Reminder: Exelixis Announces Data Presentations, Webcast Of Investor Briefing In Conjunction With 2012 ASCO Annual Meeting
16 May 2012
The company will give an oral presentation: “Efficacy of cabozantinib (XL 184) in hepatocellular carcinoma,” at ASCO June1-5, Chicago, Illinois.
MultiCell Technologies Announces Positive Preclinical Results for MCT-465 and MCT-485 in Primary Liver Cancer In Vitro Models
16 May 2012
The immune system is composed of two symbiotic elements: the innate immune system and the adaptive. Stimulation of the innate immune system plays a critical role in triggering the adaptive system to stimulate the production of antibodies. In cancer, this integrated system does not work well. MCT-465 and MCT-485 are the first of a family of prospective cancer therapeutics with immune enhancing and tumor cytolytic properties, respectively, and are being investigated as prospective treatments for primary liver cancer. MultiCell Technologies presented its findings at CIMT 2012, Europe’s largest meeting dedicated to cancer immunotherapy research and development on May 23-25 in Mainz, Germany.
BioAlliance Pharma SA: Initiation of ReLive, Phase III Clinical Trial with Livatag(R) in Primary Liver Cancer
14 May 2012
The trial aims at evaluating the effectiveness of Livatag(R) on overall survival of nearly 400 HCC patients resistant or intolerant to sorafenib at 15 French sites, with plans to extend it to a total of 30 in France and abroad. “Livatag(R) represents a different therapeutic approach, as compared with targeted therapies currently under evaluation. Its nanoparticle formulation enables Livatag(R) to bypass the resistance mechanisms of the tumor cell and assign it an interesting activity. “This clinical trial should confirm it,” declares Pr. Philippe Merle, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Principal Investigator of the study.
Fatty Acids in Fish May Lower Liver Cancer Risk
11 May 2012
Japanese investigators analyzed detailed dietary data of 90,296 adults aged 40-69 over an 11-year period in the 1990s to calculate daily fish consumption. They found that eating fish rich in n-3 polyunsaturated fatty acids (PUFAs) was inversely related to the risk of developing hepatocellular carcinoma. Dietary n-3 PUFA’s, also called omega-3 PUFAs, have long been thought to lower the risk of developing cancers, but this study found a possible protective effect of these acids against HCC. The reasons for this are not known, but it is likely that the anti-inflammatory properties of PUFAs plays a role, “…given that HCC is an inflammation-related cancer which has a background of chronic inflammation triggered by exposure to hepatitis virus infection or toxic compounds such as ethanol,” said Dr. Sawada, lead investigator of the study at the National Cancer Center, Tokyo. Because the study estimated, rather than measured consumption of fish and individual PUFAs, and because data was based on subjects’ self-reports, further research is necessary.
Cipla Slashes Prices of Selected Cancer Drugs
8 May 2012
The company has reduced the price of Sorafenib, for the treatment of HCC, by 76%. Drugs for other cancers have been reduced sharply, as well. “This initiative of price reduction is a humanitarian approach by Cipla to support cancer patients,” said Dr. YK Hamied, Chairman and Managing Director, Cipla. According to the WHO, there are about 2.5 million cases of cancers diagnosed in India every year and Cipla was the first company in the country to receive US FDA approval to manufacture oncology formulations for the US markets.
Brazilian Liver Cancer Treatment
5 May 2012
In a joint study between researchers from the University of Alabama, Birmingham and the University of Sao Paulo, Brazil, 41 patients with inoperable liver cancer underwent a treatment involving magnetic fields. A metal probe was placed in the mouth of each patient, creating a low energy magnetic field for an hour a day. The study authors claim that 17 patients had documented slowing of tumor progression and 1 patient had shrinkage of the liver tumor, but they did not go into details of how they believe magnetic fields affected the cancer. The study authors have filed a patent related to the use of their magnetic treatment for cancer.
Combination of Two Drugs Reverses Liver Tumors, Study Suggests
2 May 2012
Researchers of the Group of Metabolism and Cancer at Bellvitge Biomedical Research Institute have found that the combination of two inhibitors of the protein mTOR stops the growth of HCC cells and destroys tumor cells. The mTOR is a signaling pathway that is hyperactivated in half of those infected with HCC. Sorafenib, while effective at first, decreases its potency over time and new therapies are needed. The inhibitor rapamycin is already used as an immunosuppressant to treat specific cancers while BEZ235 is a new generation drug that inhibits mTOR. The study coordinator, Sara Kozma, noted that “because rapamycin and its derivatives are already approved for the treatment of other diseases, their combination of BEZ235, would be a rapid strategy to test the efficacy of this drug and fast track its approval for clinical use.”
Family History Ups Liver Risk
2 May 2012
World Health Organization statistics show that 700,000 people died worldwide from liver cancer in 2008, with HBV and HCV accounting for 78% of all cases of HCC. From January 1999 to July 2002, Italian researchers investigated the relationship between family history and liver cancer and found that there was a 70-fold increase in the risk of HCC in those with liver cancer in the family and markers for HBV and HCV. Speaking on behalf of the study, Professor Carlo La Vecchia said,” Monitoring individuals with family history, particularly those with hepatitis markers, could help to identify HCC at an earlier stage, and hence potentially reduce mortality from HCC.”
Brivanib Did Not Improve Overall Liver Cancer Survival, But did Show Anti-tumor Activity
30 Apr 2012
Brivanib is a selective tyrosine kinase inhibitor of vascular endothelial growth factor receptor and fibroblast growth factor receptor. Researchers from the University of Barcelona and Mount Sinai School of Medicine conducted a phase III international study with 395 HCC patients with a primary endpoint of overall survival. Brivanib did not improve survival (9.4 months for brivanib recipients vs. 8.2 months in the placebo arm), but secondary endpoints in time to progression, disease control rate and objective response rate, indicating anti-tumor activity to brivanib, showed improvement. Further studies of brivanib are currently underway.
Apricus Biosciences Receives Notice of Issuance for First PrevOnco(TM) Patent in the United States
26 Apr 2012
Apricus Bio is a San Diego-based pharmaceutical company with commercial products across numerous therapeutic classes. PrevOnco(TM) is a novel formulation of lansoprazole, a commonly marketed anti-ulcer compound. The pending patent claims certain compositions and methods related to PrevOnco(TM), a Phase-III ready cancer treatment for patients with advanced, unresectable HCC. Said Dr. Bassam Damaj, President and CEO of Apricus, “This patent represents an important step forward in our effort to develop and commercialize PrevOnco(TM) for the treatment of HCC, as it provides a runway to realize the full clinical and commercial potential of this novel therapy.”
Provectus Updates Shareholders in its Annual CEO Letter
24 Apr 2012
In April 2011, Provectus received orphan drug designation from the FDA for Rose Bengal, the active ingredient in PV-10, for the treatment of hepatocellular carcinoma (HCC). This designation will expedite the marketing of the drug to cancer patients. In addition, the company is conducting nonclinical drug-interaction studies of PV-10 with sorafenib, the standard of care for advanced HCC, to verify safety of the combination. The company expects to provide further guidance on this important indication when they are closer to commencing a Phase 2 or 3 study.
Nordion Announces Europe-Focused Phase III Clinical Trial for TheraSphere(R) Liver Cancer Treatment
24 Apr 2012
Therasphere, Nordion’s yttrium-90 glass microsphere treatment for liver cancer, will evaluate the safety and efficacy of the treatment in patients with portal vein thrombosis, as well as HCC. PVT is a complication in which a clot forms in one of the blood vessels feeding the liver and occurs in 30-40% of HCC cases. The YES-P trial is focused in Europe with a target enrollment of 350 patients, with additional locations globally to be identified later. “Nordion is excited to directly address the important question of whether TheraSphere(R) can extend the lives of this sub-group of HCC patients, where typical life expectancy remains unacceptably low,” said Mason Ross, MD, Nordion’s Vice President of Medical Affairs.
Celsion Announces Data Monitoring Committee Unanimously Recommends Continuation of Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer
23 Apr 2012
In the HEAT study, ThermoDox(R), a proprietary heat-activated liposomal encapsulation of doxorubicin, is administered intravenously in combination with radio frequency ablation (RFA). The delivery technology deposits high concentrations of doxorubicin directly to the targeted tumor. The independent Data Monitoring Committee for the multi-national HEAT study has completed a review of 652 HCC patients and unanimously recommended that the study continue based on Celsion’s reconfirmation that the endpoint of 380 patients with progression-free survival will be reached late in 2012. In addition, the company announced that it has achieved its enrollment target of 200 patients in the People’s Republic of China. “The achievement of our HEAT Study enrollment objective in China is an important milestone for Celsion, as it allows for regulatory filing in a market which accounts for over 50 percent of the 700,000 annual incidences of liver cancer worldwide,” said Michael H. Tardugno, Celsion’s President and CEO.
Childhood Obesity May Raise Odds of Adult Liver Cancer
20 Apr 2012
Danish researchers, in a study of 165,000 men and 160,000 women born between 1930 and 1989, found that adults who were obese as children had an increased risk of liver cancer. Researchers looked at birth weight and BMI and of all the participants, 252 developed HCC. The authors calculated the risk of developing HCC at age 7 increased by 12% for every 1% of BMI. That risk increased to 25% by age 13 and was consistent across both genders and all ages.
TRANSGENE: Transgene’s New Therapeutic Vaccine Candidate (TG1050) to Treat Chronic Hepatitis B (“CHB”) Reaches Pre-Clinical Proof of Concept
19 Apr 2012
Further development of the product is the result of the following positive data:
Robust and broad immune (T cell) response in pre-clinical models after one or more injections: Potent in vivo cytolysis against several epitopes; genetic stability of the vaccine. Resolution of the infection is defined at disappearance of circulating hepatitis B virus surface antigen and a measurable antibody response against this same antigen. Over the last decade, other drugs have had very little success at resolution of HBV, whereas TG 1050, in combination with standard care has great potential.
Liver Cancer Predictors in Chronic Hepatitis B Identified
12 Apr 2012
HBV DNA levels are considered the major cause of liver cancer in patients with chronic hepatitis B and those with low viral loads are considered at low risk for HCC. In these patients, scientists have found that serum levels of hepatitis B surface antigen can be used to predict risk for HCC. According to Dr. Tseng of the Buddhist Tzu Chi General Hospital in Taipei, Taiwan, “In such patients, high levels of hepatitis B surface antigen indicate higher risk for liver cancer, regardless of low hepatitis DNA levels.” Hepatitis B surface antigen quantification has become a possible predictor for evaluating viral replication and possible host immune control over HBV infection.
Liver Cancer Problem Blamed on Diabetes
5 Apr 2012
Researchers tracking data over ten years have found a 22% rise in liver cancer among South Texas Hispanics that parallels a similar rise to diabetes. While other risk factors are known to cause liver cancer, none of them were going up with the same kind of trend as diabetes, said Dr. Amelie Ramirez, professor of epidemiology at the University of Texas Health Science Center. The state of Texas tried to track hepatitis C from 2000-2005, but gave up because testing was uneven and it was almost impossible to know if the case was 10 months or 10 years old. From 1995 – 2006, self-reported diabetes for South Texas Hispanics rose from 7.6% to 9.6%; among all US Hispanics, diabetes rose from 5.9% to 7.7% over the same period. Ramirez said,”…If diabetes does turn out to be a major culprit in liver cancer, it might be a good thing.” If patients come in to be tested for the disease, doctors may be able to detect and treat liver cancer much sooner.
Promising Clinical Data in Breast and Liver Cancers Further Expand the Broad Therapeutic Potential of Peregrine’s Bavituximab
4 Apr 2012
Peregrine Pharmaceuticals, Inc. based in Tustin, CA, presented data at the Annual Meeting of the American Association for Cancer Research (AACR) on a Phase I/II trial of combining sorafenib with bavituximab to treat HCC patients. Of the nine patients enrolled in Phase I, no dose-limiting toxicities were observed and Phase II is now open for enrollment. Sorafenib is the only approved treatment for advanced liver cancer, but combination therapy with other drugs has led to unacceptable toxicities. Adam Yopp, lead investigator of the trial, said, ” Sorafenib has been shown to increase the exposure of bavituximab’s PS target on tumor blood vessel cells, and combination therapy with the two agents has shown synergistic efficacy in preclinical models.”
New Biomarker to Identify Hepatitis B-Infected Patients at Risk for Liver Cancer
3 Apr 2012
Telomeres are the caps on the end of chromosomes that protect our genetic data. Researchers at Thomas Jefferson University found that hepatitis B- infected patients with significantly longer telomeres had an increased risk of getting liver cancer compared to those with shorter telomeres. A strong correlation between telomere length and non-cirrhotic HCC could help physicians better stratify the hepatitis B population in an effort to better prevent and treat the disease. Dr. Yang, Ph.D, at Department of Medical Oncology at Thomas Jefferson, said, “This is the first study to demonstrate that relative telomere length in circulating cell-free serum DNA could potentially be used as a simple, inexpensive and non-invasive biomarker for HCC risk.”
Tremelimumab Shows Efficacy in Hepatocellular Carcinoma and Chronic Hepatitis C
3 Apr 2012
Tremelimumab is a fully human monoclonal antibody that binds on the surface of activated T lymphocytes and inhibits T-cell activation. Patients with advanced HCC caused by hepatitis C infection, when treated with the drug, stabilized for more than 12 months, according to data from a Phase II clinical trial. Dr. Ignacio Melero, MD, Ph.D. and lead investigator out of the Universidad de Navarra, Pamplona, Spain, also observed a reduction of hepatitis C virus in the patients’ blood, which was accompanied with objective enhancement of antiviral immunity. While the study group of 21 patients is small, Melero said,” The short series of patients already showing clinical activity offers clear signs for the need to extend these trials. It is unusual to spot clear signs of clinical activity with such a small number of patients, and the information on antiviral activity is also very promising.”
ApoCell’s Circulating Tumor Cell (CTC) Capture Technology First to Reliably Detect and Recover Deadly Liver Cancer Cells
2 Apr 2012
In collaboration with researchers at Virginia Commonwealth University (VCU), the company has isolated and recovered CTCs from patients with HCC. Because of the unique properties of cancer cells, ApoStream (TM) technology uses a low-level electrical field of varying frequencies to separate cancer cells from healthy ones based on these properties. Cancer cells are collected in a vial, in quantities not seen before, while non-cancerous cells are collected in a waste chamber. These findings have researchers hopeful that liver cancer could be detected much earlier, giving patients a much better chance of surviving the disease. “These studies are significant because by analyzing the collected cells, we can monitor the patient’s response to treatment, view genetic changes within the cancer and obtain new insight into the diagnosis and evaluation of each patient’s unique disease,” said Dr. Andrew Poklepovic, an oncologist and researcher at VCU.
Patients with Type II diabetes have a two-to three-fold increased relative risk of developing HCC. Metformin is a drug used to treat Type II and researchers have found that it may prevent primary liver cancer. According to the study’s senior author, Geoffrey D. Girnun, “Our research demonstrated that metformin prevents primary liver cancer in animal models. Mice treated with metformin had significantly smaller and fewer tumors than those who did not receive the medication.” Said Dr. E. Albert Reece, dean of the University of Maryland School of Medicine where the study took place,” Hepatocellular carcinoma represents a serious public health threat. This study conducted by Dr. Girnun and his colleagues is an excellent first step that may ultimately help us to prevent liver cancer in targeted populations.”
In the presentation:” Percutaneous irreversible electroporation in the treatment of hepatocellular carcinoma (HCC), and metastatic colorectal cancer (mCRC) to the liver,” doctors described how 49 patients with unresectable HCC and mCRC tumors underwent NanoKnife procedures. A total of 76 lesions were treated in 62 sessions: 20 patients had a complete response, 19 a partial response and one had stable disease as their best response. Progression free survival for HCC patients was 11.6 months. In the US, NanoKnife has been cleared by the FDA for use in surgical ablation of soft tissue, but has not been cleared for treatment or therapy of a specific diseases or condition.
One Drug Could Cure 7 Different Cancers
27 Mar 2012
Tumor cells from a variety of cancer types all express a protein called CD47- the “don’t eat me sign,” that prevents tumors from being destroyed by immune cells. A new study shows that by disrupting this signal a new cancer-fighting drug could be on the horizon. CD47 was found on primary tumors from several cancers, including HCC. In a study years ago at Stanford, researchers transplanted human tumors into the feet of mice and when they treated the mice with anti-CD47, the tumors shrank and didn’t spread to the rest of the body. They also found that while many normal cells also have CD47, cancer cells have higher levels. Said the new study’s lead author Irving Weissman,” How much CD47 a tumor made could predict the survival odds of a patient.” Weissman’s team has received a grant to move the studies from mice to human safety tests.
Radioembolisation, also called Selective Internal Radiation Therapy or SIRT, implants radioactive microspheres (yttrium-90) to selectively target tumors while sparing the remaining healthy liver tissue. In the largest study using the technique to date, 463 patients with liver-dominant tumours experienced ,” …a significantly improved and clinically meaningful survival benefit,”, according to Dr. Laurens Bester who presented the results at a conference. Among the 251 patients with colorectal liver metastases, median survival in the 220 patients treated with SIR-Spheres microspheres was 11.6 months, compared to only 6.6 months for the 31 patients who received standard or best supportive care.
Among the many pharmaceutical companies that will introduce research abstracts at the American Society of Clinical Oncology (ASCO) in June, Arqule will present on a Phase II study of tivantinib in second-line liver cancer. “Top-line data from this phase II study were released in January. Liver cancer patients who progressed after first-line therapy were randomized 2:1 to receive tivantinib or a placebo. The study met its primary endpoint with tivantinib demonstrating a 56% improvement in time to tumor regrowth.
A study in the April issue of Liver Transplantation talks about the point system employed in the wait lists for patients awaiting livers for transplant. Lead author of the study, Dr. David Goldberg with the University of Pennsylvania, said, “Our data suggest HCC candidates have substantially lower odds of waitlist removal for death or deterioration than non-HCC candidates.” Researchers determined that over time the risk of waitlist mortality or clinical decline was unchanged for HCC candidates, but increased significantly for non-HCC candidates. Dr. Patrick Northup from the University of Virginia agrees: ” The Golberg et al. study adds strength to the argument that the ‘sickest first’ policy may not be well served by the current allocation methods for HCC under the current system.”
Leading the Scientific Advisory Board (SAB) are two Key Opinion Leaders (KOL). Professor Detlef Schuppan and Professor Massimo Pinzani are internationally renowned specialists is hepatology with hundreds of published articles between them. They will collaborate with Silence, “…in hepatocellular carcinoma (HCC) and liver fibrosis with the aim to produce a development pipeline at Silence that specifically targets these disease areas.” Schuppan added: “Both the generation of highly effective siRNAs and the cell and organ specific siRNA delivery systems proprietary to Silence are most promising platforms to address currently untreatable or difficult to treat conditions of liver fibrosis/cirrhosis and HCC.”
Thermedical Announces Series A Financing Round
20 Mar 2012
Thermedical, a private company developing proprietary thermal therapy equipment for numerous clinical conditions, announced that it has a private investor to fund development of SERF. Saline-Enhanced Radio Frequency ablation is a system designed for treating malignant solid tissue, such as liver cancer, as well as difficult to treat cardiac arrhythmias. The goal of the SERF ablation system is increased survival and improved quality of life for liver cancer patients.
The European Association for the Study of the Liver and the European Organisation for Research and Treatment of Cancer publish these guidelines to define the use of surveillance, diagnosis and therapeutic strategies recommended for patients with HCC. The most common form of liver cancer, representing more than 90% of primary liver cancers and an increasing global burden, it is estimated that, by 2020, the number of cases will reach 78,000 in Europe (up from 65,000 in 2008) and 27,000 in the US (up from 21.000 in 2008). According to lead author Professor Josep M. Llovet, “Despite the availability of effective surveillance and treatment strategies for HCC, the proportion of patients currently receiving these interventions is suboptimal. When considered in light of HCC’s growing European and global incidence, it is critical that measures are implemented to increase access to surveillance, early diagnosis and effective treatment.
The first trial of a vaccine to prevent HCV infection, it follows promising Phase I results that showed the vaccine had a good safety profile, was well tolerated and that it stimulated a highly potent T-cell response in healthy volunteers. The Phase I/II trial will provide the opportunity to demonstrate the potential effectiveness of such an approach in protecting against chronic HCV infection, the leading cause of liver cancer. Three percent of the global population carries HCV, which affects the liver cells and is the leading cause of liver transplants in the US. Around 170 million people have the chronic form of the disease, which may lead to cirrhosis, liver failure and HCC.
Liver Disease Deaths up by 25%
14 Mar 2012
In a report by the NHS National End of Life Care Programme, fatal cases of liver disease are rising in England. In under a decade, there has been a 25% increase in deaths from the condition while deaths by heart disease and cancer have gone down. Liver disorders subsumed in the study include alcoholic liver disease, fatty liver disease, cirrhosis and fibrosis, liver cancer, viral liver disease and pancreatitis. While primary liver cancer is rare in England, risk factors such as hepatitis B and C and alcohol abuse can lead to it. Key findings from the study show that liver disease cause 2% of deaths in England, but is rising, that more men than women die from it (60% are men and 40% are women) and that 90% of deaths are in people under that age of 70.
The Indian patent office approved Natco Pharma, Ltd’s application to produce the kidney and liver cancer treatment, sorafenib. This was the first case of compulsory licensing under India’s unique patent laws, passed in 2005, and effectively ends Bayer’s intellectual property rights for their drug in India. Bayer markets sorafenib as Nexavar for about $5600 a month in India under a 2008-2020 patent. Natco will market their version for Indian patients at $175 a month. India’s generics industry has been a focus of Western pharmaceutical companies who say the 2005 Patent Act fails to guarantee investor’s rights. Lawyer Anand Grover for the Cancer Patients Aid Association, who was not involved in arguing the Nexavar case, said,” It would be interesting to see whether multinationals will change their practices in developing countries.”
DC Beads for Liver Cancer
8 Mar 2012
Apollo Hospitals in Bhubaneswar, India has used a new therapy for liver cancer patients. DC beads are tiny spheres suffused with chemo drugs that are delivered directly into the small blood vessels that supply the liver with nutrients. The therapy delivers a more potent dose of chemotherapy to the tumor while reducing the side effects by keeping the drugs out of the bloodstream to the rest of the body. The first treatment was on a 73-year old HCC patient and, according to interventional radiologist Dr. Manas Ranjan Kar, the one month follow-up has shown a significant reduction in tumor size.
Arrowhead Research Corporation, a nanomedicine company with development programs in RNA therapeutics, released a white paper describing the health problem posed by the hepatitis B virus. “Hepatitis B is a global health problem without effective treatment for a vast number of patients with chronic disease. The World Health Organization estimates that 360 million people, or 5% of the world’s population, suffer from chronic hepatitis B,” said Christopher Anzalone, Ph.D, President and CEO of Arrowhead. Anzalone goes on to say,” Extensive data from our development programs across multiple in vitro and animal models suggest that we can… produce a powerful and highly specific candidate to fight HBV.” More detail on the white paper will be provided at upcoming conferences and through future publication in peer-reviewed journals. The white paper is available on Arrowhead’s home page: www.arrowheadresearch.com.
Boston University researchers have discovered a promising new target protein, the transcription factor LSF. Transcription factors are proteins that bind genomic DNA near the start of genes that can either promote or inhibit the copying of the DNA. LSF is found at high levels in the tumor tissue of HCC patients and BU researchers identified small molecules that inhibit LSF growth, which in turn slows cancer growth. One such molecule, Factor Qunolnone Inhibit 1 (FQI 1), not only inhibits LSF activity, but also retards its ability to proliferate. FQI 1 kills liver cancer cells while healthy cells are unaffected and supports “…further development of LSF inhibitors as a promising new chemotherapy treatment for liver cancer.”
Using two existing treatments on terminal liver cancer patients, Korean doctors at the National Cancer Center have doubled the survival time of those patients. Embolization, which removes blood vessels that supply cancer cells and chemotherapy, using Nexava to prevent blood vessels from being created, were the treatments administered to 50 terminal liver cancer patients not eligible for surgery from July 2009 to May 2011. Therapeutic effect maintenance duration, the period in which existing cancer cells no longer grow or no new cancer cells are created, went from four to seven months. Dr. Park Joong-won, leader of the team, said, “This study has shown for the first time the prospects of extending the lives of liver cancer patients by combining embolization and the targeted therapy.”
In a study conducted by two Japanese scientists from Dokkyo University, in cooperation with the Cambodian National Center for Parasitology, Entomology and Malaria, a freshwater parasite found in 7 freshwater species of fish was linked to liver cancer in humans. Human liver fluke is a flatworm that,” …can trigger human liver cancer by creating harmful cell mutations, causing tumor growth and stopping normal cell death,” said Dr. Char Meng Chuor, National Center director. When a person eats raw fish from any of these species, the flatworm inhabits the liver. “However, we can prevent the disease easily by eating only well-cooked fish,” said Chuor. Cases of liver cancer caused by eating raw fish have also been reported in Laos, Vietnam, the Philippines and Indonesia.
Of the 1074 HCC patients undergoing partial hepatectomy enrolled in the study, 374 were under the age of 55, 700 were older. Post-operative follow-up showed that the younger patients had better liver functional reserve, but more aggressive tumor factors than did the older group. Despite a difference in the 10-year survival rate between the groups (41.3% for the younger, 28.8% for the older), analysis of the data found that the incidence of tumor return in the younger group was comparable to that of the older group. The study concluded that age is not a risk factor in determining the survival of HCC patients who underwent resection.
Hepatitis C results in chronic disease in 50% to 90% of those infected and is the primary indication for liver transplantation. Two new treatments received FDA approval in May 2011: telaprevir (Incivek) and boceprevir (Victrelis). Either drug must be combined with the traditional therapy of interferon and ribavirin to combat the development of resistance within the virus. Telaprevir was evaluated in three studies and achieved sustained viral response in 80% – 90% of patients. In a clinical trial, boceprevir showed an effect in fighting HCV in 67% of patients.
Dr. Brent Tetri, director of the division of gastroenterology and hepatology at St. Louis University School of Medicine was given the award by The Lottie Caroline Hardy Charitable Trust to study the connection between a fast food diet and an illness called nonalcoholic steatohepatitis (NASH). The disease is seen in 5-10% of people and the number of NASH cirrhosis cases in the U.S. has shot up in recent years. Says Tetri: “The condition puts people at risk for developing cirrhosis and liver cancer, which is the cancer with the fastest rising mortality rate. With the grant, we will continue studying NASH in mice, with the goal of understanding more about its cause and connection to liver cirrhosis and liver cancer.”
Nordion, a leader in providing products and services for the prevention, diagnosis and treatment of disease, has invited 100 liver cancer specialists in North America to attend the summit. “The TheraSphere Summit is for physicians who are already familiar with the device but want to improve their knowledge and hone their skills to better serve their patients,” said Dr. Salem, Professor of Radiology, Medicine and Surgery and Director, Interventional Oncology at Northwestern University in Chicago. TheraSphere is a liver cancer therapy that injects millions of small, radioactive yttrium-90 beads directly to the tumor via blood flow. It is used in patients with unresectable HCC or ones with portal vein thrombosis and is approved by the FDA under a Humanitarian Device Exemption.
The company’s drug CF-102 is an oral small molecule that fights HCC and was found to be safe in preclinical and Phase I clinical trials. The FDA status is granted for drugs being developed for diseases treating 200,000 people or less and provides incentives, preferences and seven years of marketing exclusivity.
Hepatitis C Deaths Up, Baby Boomers Most At Risk
21 Feb 2012
A CDC study just published showed an increase in death rates from hepatitis C, with 75% of those deaths occurring in middle-aged people in the 45-64 range. The virus affects 170 million people worldwide with an estimated 3.2 million of those being Americans, according to Dr. John Ward, hepatitis chief at the Centers for Disease Control. Analysis of a decade of death records showed that in 2007 there were 15,000 American deaths due to hepatitis C that surpassed the nearly 13,000 deaths caused by the better-known AIDS virus. While sharing a dirty needle is still the greatest risk factor, blood transfusions before 1992, when testing of the blood supply began, was commonly known to spread hepatitis C. Baby boomers have simply lived longer in a time where the risk was higher for the spread of the virus. “One of every 33 baby boomers are living with hepatitis C infection,” according to Ward and federal officials are considering whether baby boomers should get a one-time test to check for this virus that takes decades to its damage.
BGI is the world’s largest genomics organization; the Asia Cancer Research Group (ACRG) is a not-for-profit organization fighting lung and liver cancer, the most commonly diagnosed cancers in Asia. The goal of the joint venture is to create a best-in-class data source and to accelerate research and development by sharing this data with the scientific community. ACRG will provide samples of lung and liver cancer tissues, and BGI will sequence these samples and produce high-quality data output and provide bioinformatics analysis. Dr. Mao Mao, President of ACRG, says:” The collaboration will accelerate the establishment of a pharmocogenomic database for Asian lung and liver cancers.” The hope is to develop new diagnostic methods and therapies for these two common cancers.
Nordion Inc., a leading provider of health science products on the global market, celebrated the first anniversary of the radioembolic liver cancer therapy in the Republic of Turkey. The therapy targets millions of tiny glass beads containing yttrium-90 to the tumor. Since the first treatment in Ankara in December 2010, more than 80 patients have undergone treatment across the country. According to GLOBOCAN, the World Health Organization’s agency for cancer data and research, in 2008 more than 1,090 new cases of primary liver cancer were diagnosed in men and women in Turkey, with approximately 1,050 deaths that same year. “Nordion made a strategic decision to launch TheraSphere in Turkey last year and our commercial efforts, together with those of our Turkish distributor, Eczacibasi Monrol Nuclear Products, mean more physicians in the region are aware and now have access to this innovative treatment, to the benefit of their patients,” said Kevin Brooks, Nordion Senior Vice President of Sales and Marketing.
At the 22nd Conference of the Asia Pacific Association for the Study of the Liver (APASL), in Taipei, Taiwan, the focus was on new ideas for the treatment of chronic hepatitis B and C, non-alcoholic fatty liver disease and liver cancer. According to APASL President Kao Jia-horng, the hope is that the conference can educate medical staff to provide better care to patients. Ideas discussed included establishing a set of guidelines to govern noninvasive techniques to diagnose liver diseases and that the future treatment of hepatitis C patients in Asia be based on the quantity of virus genes detected. German virologist and Nobel Prize winner Harald zur Hausen gave a speech that explained how liver cancer caused by hepatitis B virus infections works similarly to cervical cancer cause by human papillomavirus infections. Hausen said that this relationship between infections and cancer is applicable to liver cancer studies, as a whole. It is the first time in a decade that Taiwan has hosted this event.
CHEMOSAT is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while protecting healthy tissue. Delcath and the Instituto Europeo di Oncologia (IEO) introduced the delivery system at a press conference as a critical new treatment option for patients who suffer from inoperable liver-dominant metastases. The IEO started CHEMOSAT treatments on January 31, 2012 and has treated three patients so far: two with liver metastases stemming from ocular melanoma and one from gastric cancer. The patients responded well to treatment and their condition is expected to improve. “The preliminary results from these procedures reaffirm our confidence of CHEMOSAT’s ability to help patients suffering from cancers in the liver,” said Eamonn P. Hobbs, president and CEO of Delcath.
An article published in Molecular Therapy validates the selectivity of JX-594 in targeting and killing a broad range of cancer cells. “We believe that this study clearly explains how JX-594 is able to specifically target and destroy cancer cells in patients while leaving the surrounding healthy cells intact,” said David H. Kirn M.D. president and chief medical officer of Jennerex. Objective tumor responses have been seen in patients with liver, colon, kidney, lung cancer and melanoma.
The company announced that in its open-label, two-arm international study that investigated the efficacy and safety of the drug the goal of halting progression of HCC in at least 20% of patients was achieved ahead of schedule. Resminostat was used in this study both as a monotherapy and in combination with sorafenib and this success was in both arms of the study for at least 12 weeks.
Fatal Side Effects in 3 Cancer Therapies
6 Feb 2012
Scientists at Dana Farber Cancer Institute conducted analysis of cancer-fighting drugs Nexavar (kidney and liver), Sutent (kidney and gastrointestinal stromal tumor) and Votrient (kidney). Study leader, Toni Choueiri, MD, assistant professor of medicine at Harvard Medical School, found through meta-analysis of 10 clinical trials that fatal side effects were seen in 1.5% of patients that used these three drugs versus 0.7% of patients given drugs that have been around longer or a placebo. Risks of fatal bleeding, heart attacks, heart failure and liver failure are low, but,” said Choueiri: “The patient should be given all the information, and then he or she can balance the pros and cons in deciding whether to take the next step is to treatment.”
New Treatment For Liver Cancer Patients
5 Feb 2012
The DEBIRI (Drug-Eluting Beads delivering Irinotecan) treatment is non-surgical alternative for patients suffering from both primary or secondary liver cancer. DEBIRI delivers, via catheter into the hepatic artery, microscopic chemotherapy beads directly to the tumor for maximum potency and minimal side effects. BMI The Alexandra Hospital is the first in the North West of England to provide this treatment.
SARAH (SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma) is a French randomized controlled trial that directly compares the effectiveness of radioembolization with yttrium-90 resin microspheres versus sorafenib, the current standard of care for patients with advanced non-surgical HCC. While sorafenib has proven to increase overall survival in patients, about 80% experience treatment-related side effects. Also known as Selective Internal Radiation Therapy (SIRT), radioembolization is minimally invasive and, via millions of radioactive microspheres, can deliver up to 40 times the dose of conventional radiotherapy directly to the tumor while sparing healthy tissue. Professor Valerie Vilgrain, MD, PhD and principal investigator for the study at the Sorbonne, says” Around 20 specialist cancer centres throughout France will be involved in this trial.”
Known for their cholesterol lowering properties, statins may also lower the risk of liver cancer, according to a new study. From 1997-2008, more than 33,000 individuals with Hepatitis B who took statins were found to have a lower likelihood of developing the cancer. In addition, the longer a person took statins, the greater the reduction. Dr. Pau-Chung Chen, a professor of environmental medicine at the University of Taipei, said: “Statin use is not only a benefit to preventing cardio vascular diseases, but also an additional, convenient and acceptable strategy for preventing hepatocellular carcinoma.” The study appeared in the online Jan. 23 issue of Journal of Clinical Oncology.
Researchers from the Metabolomic Unit at CIC bioGUNE and led by Dr. Martinez has shown a relation between high levels of HuR protein and the development of HCC by means of a process called neddylation. An enzymatic reaction, neddylation helps protect certain proteins necessary for the proliferation of HCC tumors. Overexpression of the HuR protein may be linked to malignancy of HCC tumors, and serve as an early warning for physicians and their patients. The research was published in the Hepatology journal.
Researchers at the Massachusetts General Hospital Center identified a new genetic signature that for bile duct cancer that could lead to targeted treatment for the disease. Bile duct cancer occurs in a duct that carries bile from the liver to the small intestine and patients, “…generally have a poor prognosis,” according to Dr. Andrew Zhu, study co-senior author and director of Liver Cancer Research at the MGH Cancer Center. Researchers found that growth-enhancing mutations in two genes account for nearly 25% of bile duct tumors that develop in the liver and it may be possible to develop drugs that target this mutation and stifle tumor growth.
Allan Lee Cohn, M.D. Medical Director of Research at the Rocky Mountain Cancer Centers reported positive preliminary data from the randomized discontinuation trial of the drug at the 2012 Gastrointestinal Cancers Symposium this week in San Francisco. In patients with or without prior sorafenib therapy, there was evidence of tumor regression in 78% of participants and median progression-free survival was 4.2 months. This rate was similar to patients treated with or without sorafenib alone. “These compelling results highlight cabozantinib’s potential clinical utility in HCC,” said Cohn and warranted a further study of the drug in patients with HCC.
New research from the lab of Klaus Kaestner, PhD, professor of Genetics in the Perelman School of Medicine at the University of Pennsylvania, has found that men are four times more likely to develop liver cancer compared to women. The sex hormones estrogen and androgen have been known for a long time to, respectively, prevent and promote the cancer, but why is unclear. Kaestner has found that what matters is whether the sex hormones bind to a group of proteins, called Foxa 1 and 2. Male mice develop more tumors than females, but in the study, this gender-related difference was reversed “… in mice genetically engineered by the team to lack the Foxa genes…” The actions of the sex hormones in the liver are Foxa dependent, which explained the reversal in cancer risk.
Liver and Thyroid Cancer Rates Rise
18 Jan 2012
Statistics Canada reports a “relatively large” increase in liver cancer. The study, conducted between 1997-2008, found a five-year prevalence proportion of 6.2 cases per 100,000 persons on Jan. 1, 2008. Explanations for the rise in incidence included an influx of immigrants where hepatitis B and C are more common, a rise in hepatitis C infection linked to intravenous drug use and higher rates of obesity and Type 2 diabetes.
Elekta Symmetry’s(TM) 4D image guidance technology has been used by Riverside and University of Virginia Radiosurgery Center clinicians in patients with lung or liver tumors. Now, for patients whose tumors move while breathing, a clear, blur-free image can help physicians target tumors better while decreasing the dose to healthy surrounding tissue.
The company stated that its experimental therapy, tivantinib, showed positive results in a Phase 2 trial. When used alone, the drug extended the cancer’s time to progression by 56 percent. Side effects include fatigue neutropenia and anemia, which subsided with a lower dosage. Company chief medical officer Dr. Brian Schwartz said: ” These finding represent the first randomized data reported with a c-Met inhibitor administered as a single agent in HCC.”
Merck Millipore announced that it would be the initial distributor of HepaRG(TM) human hepatic cells for use in disposition of drug candidates for HCC and proper assessment of toxicity. Umesh A. Patel, PhD, Director, Lead Discovery, said that supply of primary cells can be unpredictable and that they lose specific liver functions which impact drug research adversely. According to Patel,” In contrast, HepaRG(TM) cells reproducibly express the activities drug metabolizing enzymes and transporters to facilitate ADME/tox studies.”
10 Jan 2012
In a systematic review of 45 studies involving 9,330 HCC patients, researchers found that new antivirals were no better than old at preventing the disease in patients with chronic hepatitis B. Dr. Ashwani K. Singal, at the meeting of the American Association for the Study of Liver Diseases, reported that whether patients were given older drugs, like lamivudine or adefovir, or newer ones, like entecavir, telbivudine, or tenofivir, the rate of HCC was almost identical. According to Singal, ” … the surprise stems from the fact that the newer agents have a low rate of drug resistance and achieve continued suppression of hepatitis B virus DNA during prolonged therapy.” He speculated that the relatively small number of patients treated with the newer agents could explain their apparent “nonsuperiority” and that more, larger studies were needed to truly know whether the newer antivirals were better than the old.
Liver cancer cases have tripled in the United States over the last 30 years, according to two new studies from the Mayo Clinic, and hepatitis C infection and obesity could be to blame. Dr. W. Ray Kim, gastroenterology and hepatology specialist and principal investigator of the study examined the Rochester Epidemiology Project, a national database on inpatient and outpatient care. Kim and his team found a rate of 6.9 cases of HCC per 100,000 people, higher than the 5.1 cases per 100,000 estimate of the U.S. National Cancer Institute. The study found that hepatitis C is a risk factor and that 11% of HCC cases were linked to obesity, particularly fatty liver disease. The second study found a significant number of HCC cases among Somalis living in the United States linked to both hepatitis B and C. Somalis typically have a higher rate of hepatitis B. Dr. Kim said the findings from both studies could help doctors diagnose HCC earlier and save lives.
The European Commission funded a project called Patient-Specific Simulation and Pre-Operative Realistic Training (PASSPORT) in an effort to help doctors evaluate patients for cancer surgery. Liver resection is a lower-risk procedure than transplantation but questions such as precise tumor location and post-surgical liver function made assessment of which procedure to use difficult. PASSPORT is an online service that can take radiological images and create a virtual liver specific to the patient so that doctors can make that assessment. The ultimate goal is to let surgeons use multi-layered virtual models of the body to “…improve diagnosis and surgery and help to save lives.” according to Neelie Kroes, digital agenda commissioner of the project.
Mirna, a biotechnology company pioneering microRNA replacement therapy for cancer, announced several accomplishments in 2011 related to its liver cancer drug MRX01. According to company President and CEO, Dr. Paul Lammers, they obtained: ” …dramatic preclinical results with MRX01 in an orthotopic mouse model of hepatocellular carcinoma using the SMARTICLES oligonucleotide delivery technology.” MRX01 is the proprietary tumor suppressor microRNA, miR-34. Lammers hopes this formulation will lead to a Phase I clinical trial for the drug in early 2013.
An animal study at the Ohio State University Comprehensive Cancer Center and the Mayo Clinic may have found a treatment that targets and blocks a microRNA that is important in liver cancer. The findings, published in the journal Cancer Research, show researchers designing a molecule, called an antisense oligonucleotide, that mirrors the cancer molecule, microRNA-221. The mirror molecule binds and blocks the action of miR-221 in human liver cancer transplanted into mice. Half the treated animals were alive at 10 weeks versus none of the controls; antisense oligonucleotides significantly reduced levels of miR-221 in both tumor and normal liver samples; and treatment with this cancer blocker caused a three-fold increase in the activity of three tumor-suppressor genes. Thomas Schmittgen, principal investigator at Ohio State University said: ” Overall, this study provides proof-of-principle for further development of mincroRNA-targeted therapies for hepatocellular carcinoma.”
Can-Fite is an Israeli biotechnology company that develops small molecule drugs for the treatment of inflammatory and liver diseases. CF102 binds successfully to the A3 adenosine receptor, which is highly expressed in tumor cells, and induces cell death. The study was led by Dr. Salomon M. Stemmer, Institute of Oncology, Davidoff Center, Rabin Medical Center, which included 18 patients with HCC, most of whom had failed prior treatment with Nexavar. The two objectives were to evaluate long-term safety of CF102 at three different dose levels and to document evidence of clinical efficacy. Both objectives were met. In fact, the median survival time was 7.8 months, which was very encouraging, and for Child-Pugh B patients, 9.4 months, the longest survival time that has been reported for this population.
Selective internal radiation therapy, or SIR-Spheres, has been found safe and effective in patients who have failed other chemotherapy options. In addition, this therapy has been recently been approved for patients in the U.S. and now, Dr. Jakobs Tobias, Associate Professor of Radiology, Dept. of Radiology at Munch University, German has introduced the treatment for inoperable liver cancer in India. Tiny beads of resin, called microspheres, coated with the radioactive atom (yttrium-90), are carried in the bloodstream directly to the liver tumors where they lodge and deliver a more potent dose of radiation over a longer period of time. The treatment is more selective than conventional external beam radiation and has the added advantage of being an outpatient procedure.