Scientific Peer Review of Congressionally Directed Medical Research Programs’ PRCRP for the Department of Defense
The Congressionally Directed Medical Research Programs’ (CDMRP), Peer Reviewed Cancer Research Program (PRCRP) consumer advocate Andrea Wilson recently participated in the evaluation of research applications submitted to the PRCRP. President Andrea Wilson was nominated for participation in the program by Blue Faery last year. As a consumer reviewer, Ms. Wilson was a full voting member, along with prominent scientists at meetings to help determine how the $90 million appropriated by Congress for Fiscal Year 2019 will be spent on cancer research.
Consumer reviewers are asked to represent the collective view of patients by preparing comments on the impact of the research on issues such as diagnosis, treatment and quality of life. When commenting on serving as a consumer reviewer, Ms. Wilson, “This program allows patients and caregivers to actively participate in the future of cancer research. It is an amazing experience.”
Consumer advocates and scientists have worked together in this unique partnership to evaluate the scientific merit of research applications since FY09. Colonel Stephen J. Dalal, Director of the CDMRP, expressed his appreciation for the consumer advocate’s perspective during the scientific review sessions. “Consumer advocates are an integral part of the CDMRP’s scientific review process. They provide a key ingredient to the review process, the patient’s perspective, which is real and urgent. The collaboration of Consumer advocates alongside the scientists’ subject matter expertise is a truly unique collaboration that is difficult to find in most medical research programs.”
Scientists applying propose to conduct innovative research that successfully promotes high impact research for cancer, prevention, detection, treatment and survivorship. The PRCRP fills important gaps not addressed by other funding agencies by supporting groundbreaking, high-risk, high-gain research while encouraging out-of-the-box thinking.
More information about the CDMRP’s PRCRP is available on the website: https://cdmrp.army.mil/prcrp/default.
Public Affairs Specialist
Supporting the Congressionally Directed Medical Research Programs, USAMRMC
Help us learn more about the liver cancer community
Blue Faery has partnered with Cancer Support Community (CSC) to encourage liver cancer patients and caregivers to join the Cancer Experience Registry.
The Cancer Experience Registry: Liver Cancer is a research survey to understand the personal experiences of people impacted by liver cancer. By joining you will help the cancer community gain insights about the social and emotional needs of liver cancer patients, families and caregivers.
The Cancer Experience Registry is open to anyone who been diagnosed with liver cancer as well as those relatives or friends that assist with their care.
- Go to www.cancerexperienceregistry.org.
- Register and complete your profile.
- Fill out the survey.
- Download the flyer to share with others.
Thank you for sharing your story. We really appreciate it!
Eisai’s Chief Scientific Officer Says “I Was One of Those Families”
Article for Blue Faery by Kenichi Nomoto
Interviewed by Cindy Gessell, Senior Consultant, Eisai Inc.
Thirty-five years later, driven by personal and professional passion, Dr. Kenichi Nomoto expands the liver cancer treatment landscape
Kenichi Nomoto, Ph.D., Chief Scientific Officer, works in the Oncology Business Group at Eisai. Dr. Nomoto has always been passionate about developmental biology for professional and personal reasons. As an undergraduate student, this interest led him to pursue a career in research. In 1984, Dr. Nomoto joined Eisai where he worked as a bench scientist for discovery research in cardiovascular diseases. This opportunity guided him to learn more about vascular biology. This area led to the development of LENVIMA® (lenvatinib), a prescription medicine that is used by itself for a type of liver cancer, Hepatocellular Carcinoma (HCC), when it cannot be removed by surgery.
What drove your passion for oncology?
Eisai has a unique corporate philosophy. We call it our human health care (hhc) mission, which means we give our first thoughts to patients and their families. This philosophy inspires and motivates us to create and deliver new medicine for people who are suffering from diseases. In 1999, I was one of those families. My father passed away after a two-and-a half-year battle with HCC. At that time, there was a lack of systemic therapeutic options for unresectable advanced HCC. My family and I lived through a very difficult time while he was suffering. I recognized that there was a strong unmet medical need for the treatment of this disease.
Coincidentally, the LENVIMA project had commenced in 1999 in Eisai Tsukuba Research Laboratories in Japan. Eisai gave me the unique opportunity to work on this project as a biology co-leader for discovery research in 2000. In 2018, sixteen years after we selected the molecule, our dream came true. The U.S. Food and Drug Administration approved LENVIMA as the first new first-line systemic treatment option for patients with unresectable HCC in over a decade.
Can you share how LENVIMA was discovered in the laboratory?
In 1990s, cytotoxic chemotherapy, which kills cancer cells, was the common therapeutic option for cancer treatment. As cytotoxic agents inhibit cell division, they may also damage normal cells. Since cytotoxic agents are not able to tell the difference between healthy and malignant cells, it is often difficult to balance the treatment benefit versus the wide variety of adverse events.
In the early 1970s, Dr. Judah Folkman at Children’s Hospital in Boston hypothesized that tumors could not grow beyond a certain size without a blood supply. They must have some mechanism to create the formation of blood vessels. At first, researchers neglected his theory; they focused on chemotherapy. A crucial moment came in the late 1980s with the discovery of vascular endothelial growth factor (VEGF). It is a protein that blocks the growth and development of vascular cells that form new blood vessels.
These new scientific discoveries gave us the idea to test VEGF-targeted therapy in the laboratory. The goal was to extend the overall survival of patients living with cancer while maintaining a safety profile that may be manageable. HCC is characterized by a well-developed tumor vascular network, which provides the rationale for VEGF-targeted therapies for the treatment of unresectable HCC. In 1999, the oncology community was still skeptical that blocking the growth and development of these cells could be a viable cancer treatment option. Yet, our team, led by Eisai researchers Drs. Akihiko Tsuruoka and Yasuhiro Funahashi, pursued this therapy.
In 2007, a treatment was approved in the United States and Europe for advanced HCC. Since then, several medicines have been tested with unsuccessful results for more than 10 years, until LENVIMA. LENVIMA is used by itself as a treatment for HCC when surgery cannot remove the tumors.
Today, besides becoming a treatment option for unresectable HCC in the U.S., LENVIMA has also been approved to treat advanced liver cancer in the European Union, Japan, South Korea, China, Taiwan, Australia, Canada and several other countries. We hope that more countries will use it in the future.
On behalf of the Eisai research team, I am very grateful for all the patients, their families and health care providers who participated in the clinical trials. Our Eisai research team promises to continue research of LENVIMA so that we may provide more benefits to appropriate patients. As part of Eisai’s human health care mission, we work to satisfy unmet medical needs and contribute to the health and well-being of people living with unresectable liver cancer.
IMPORTANT SAFETY INFORMATION
LENVIMA may cause serious side effects, including:
- high blood pressure (hypertension): High blood pressure is a common side effect of LENVIMA and can be serious. Your blood pressure should be well controlled before you start taking LENVIMA. Your healthcare provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose of LENVIMA, or stop your treatment with LENVIMA.
- heart problems: LENVIMA can cause serious heart problems that may lead to death. Call your healthcare provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles.
- problem with blood clots in your blood vessels (arteries): Get emergency medical help right away if you get any of the following symptoms: severe chest pain or pressure; pain in your arms, back, neck, or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; sudden severe headache; sudden vision changes.
- liver problems: LENVIMA may cause liver problems that may lead to liver failure and death. Your healthcare provider will check your liver function before and during treatment with LENVIMA. Tell your healthcare provider right away if you have any of the following symptoms: your skin or the white part of your eyes turns yellow (jaundice); dark, “tea-colored” urine; light-colored bowel movements (stools); feeling drowsy, confused, or loss of consciousness.
- kidney problems: Kidney failure, which can lead to death, has happened with LENVIMA treatment. Your healthcare provider should do regular blood tests to check your kidneys.
- increased protein in your urine (proteinuria): Proteinuria is a common side effect of LENVIMA and can be serious. Your healthcare provider should check your urine for protein before and during your treatment with LENVIMA. If you develop protein in your urine, your healthcare provider may decrease your dose of LENVIMA or stop your treatment.
- diarrhea: Diarrhea is a common side effect of LENVIMA and can be serious. If you get diarrhea, ask your healthcare provider about what medicines you can take to treat your diarrhea. It is important to drink more water when you get diarrhea. Tell your healthcare provider or go to the emergency room if you are unable to drink enough liquids and your diarrhea is not able to be controlled.
- an opening in the wall of your stomach or intestines (perforation) or an abnormal connection between two or more body parts (fistula): Get emergency medical help right away if you have severe stomach (abdomen) or chest pain.
- changes in the electrical activity of your heart called QT prolongation: QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider will do blood tests before and during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and may check the electrical activity of your heart with an ECG.
- low levels of blood calcium (hypocalcemia): Your healthcare provider will check your blood calcium levels during treatment with LENVIMA and may tell you to take a calcium supplement if your calcium levels are low.
- a condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Call your healthcare provider right away if you get severe headache, seizures, weakness, confusion, or blindness or change in vision.
- bleeding: LENVIMA may cause serious bleeding problems that may lead to death. Tell your healthcare provider if you have any signs or symptoms of bleeding during treatment with LENVIMA, including severe and persistent nose bleeds; vomiting blood; red or black (looks like tar) stools; blood in your urine; coughing up blood or blood clots; heavy or new onset vaginal bleeding.
- change in thyroid hormone levels: You may have changes in your thyroid hormone levels when taking LENVIMA. Your healthcare provider may need to change your dose of thyroid medicine while you are taking LENVIMA. Your healthcare provider should check your thyroid hormone levels before starting and every month during treatment with LENVIMA.
- wound healing problems: If you need to have a surgical procedure, tell your healthcare provider that you are taking LENVIMA. LENVIMA should be stopped until your wound heals.
The most common side effects of LENVIMA in people treated for thyroid cancer include tiredness; joint and muscle pain; decreased appetite; weight loss; nausea; mouth sores; headache; vomiting; rash, redness, itching, or peeling of your skin on your hands and feet; stomach (abdomen) pain; and hoarseness.
The most common side effects of LENVIMA in people treated for kidney cancer include tiredness, joint and muscle pain, decreased appetite, vomiting, nausea, mouth sores, swelling in your arms and legs, cough, stomach (abdomen) pain, trouble breathing, rash, weight loss, and bleeding.
The most common side effects of LENVIMA in people treated for liver cancer include tiredness; decreased appetite; joint and muscle pain; weight loss; stomach (abdomen) pain; rash, redness, itching, or peeling of your skin on your hands and feet; hoarseness; bleeding; change in thyroid hormone levels; nausea.
LENVIMA may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of LENVIMA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information.
Learn more about the Eisai Assistance Program and other support at www.LenvimaReimbursement.com or by calling 1-866-61-EISAI (1-866-613-4724).
For more information about LENVIMA please see available full Prescribing Information.
Seeking HCC Patients Taking Lenvima
Seeking HCC Patients Currently Taking Lenvima
If you reside in the US, have been diagnosed with Stage III or IV unresectable Hepatocellular Carcinoma (primary liver cancer), and you are currently taking Lenvima, we have a paid opinion market research study that may be of interest to you.
Connected Research and Consulting, a medical market research company, is currently managing a project with the objective to speak with patients about their experiences.
We are offering $200 for a 60-minute telephone/web interview. There is a small homework assignment for an additional $100. The interviews will begin September 12th at a time that is convenient for you.
If you are interested, please click the link below to answer a few brief questions to see if this study is a good match for you.
We are compliant with HIPAA and all Market Research ethical standards. Your information will always remain protected.
If you have any questions or would like to speak further about this opportunity, please email Catlin at
- firstname.lastname@example.org or
- call her directly at 561-440-7550.
Can we beat chronic liver disease and reduce the risk of liver cancer?
By Mark Feitelson, Ph.D., Department of Biology, Temple University, Philadelphia, PA 19122
Millions of people worldwide suffer from chronic liver disease (CLD) associated with hepatitis B and C virus infections, alcoholism and obesity. These conditions reduce the quality of life and elevate the risk of developing liver cancer. Liver cancer is among the most prevalent types of cancers in the world. There is no cure for CLD and few options for treating liver cancer. By the time most people are diagnosed with liver cancer, the tumor has spread too far in the body for curative treatments, such as surgery or liver transplantation. Among the roughly 700,000 new cases of liver cancer diagnosed yearly, at least 600,000 of these people die. Moreover, the frequency of CLD and liver cancer are increasing in many parts of the world.
Through research in his lab at Temple University, Dr. Mark Feitelson has revealed a potentially breakthrough approach to treating these diseases. There is increasing evidence in the medical literature that the composition of bacteria and other microbes in the intestine are altered among people with CLD and liver cancer. Since these organisms make compounds that help to keep us healthy, the imbalance in bacteria seen among ill patients may mean that there is also an imbalance in the composition and levels of compounds that are available to keep us healthy. His lab followed up on this observation and identified several compounds that have strong anti-inflammatory activities, which means they may be effective against CLD. These compounds also have strong anti-cancer properties meaning they may delay, prevent and/or be useful for the treatment of liver cancer. To test this, Dr. Feitelson’s lab used a mouse model in which hepatitis B virus triggered CLD, which progressed to liver cancer by 10 months of age. When these mice were fed with a mixture of the compounds above, the incidence of both CLD and liver cancer was cut in half. Among mice that developed tumors, they were fewer and smaller. At these doses, there was no evidence of toxicity, which is a problem with most other treatment approaches. Further, when these compounds were given to mice with already existing tumors, the tumors shrank in size, indicating that they had a direct anti-tumor effect.
The big question then came up as to whether these compounds were effective in people. To test this, Dr. Feitelson’s lab chose to give these compounds to a handful of patients suffering from psoriasis, which is a chronic inflammatory disease of the skin. Many of the inflammatory immune responses present in CLD were also present in people suffering from psoriasis. The prediction was that these people, like the mice, would be responsive. When these compounds were provided orally to people with psoriasis, their lesions improved within a few weeks, with no side effects. The lab chose psoriasis because it was simple and fast to observe lesions on the skin. In contrast, resolution of lesions in the liver would occur more slowly, and would take a much longer time to evaluate whether the compounds were working.
This combined information now suggests that there may be a simple, effective and non-toxic approach to the treatment of CLD, liver cancer and possibly many other chronic inflammatory diseases. This is the basis for the creation of SFA Therapeutics, Inc., which is now looking for collaboration and investment to further develop and apply these exciting and promising findings.
Dr. Jinsil Seong Wins 2019 Blue Faery Award
Professor Seong is one of a few who pioneered radiotherapy of Hepatocellular Carcinoma. She has devoted her entire career on radiotherapy of HCC by practicing, educating and pursuing clinical research. With her enthusiasm and devotion overcoming a minority issue not only in specialty (radiation oncology) but also in gender (women), she has served as a president of the Korean Liver Cancer Association. Additionally, she is the president-elect of the Asia Pacific Primary Liver cancer Expert (APPLE) association, which is a world leading liver cancer association.
Seeking adults with liver cancer for research study
Have you been diagnosed with liver cancer?
IQVIA, a global healthcare research company, is looking for people with liver cancer to participate in a telephone research study. They want to understand how people with liver cancer feel in terms of symptoms, and impact on quality of life. Qualified study participants will receive a $150 gift card.
Click to learn more and see if you qualify http://bit.ly/2sC8vpVWeb.
Download flyer here: Liver Cancer Research Study
Dr. Ghassan Abou-Alfa wins the 2018 Blue Faery Award
Dr. Ghassan Abou-Alfa from Memorial Sloan-Kettering Cancer Center specializes in the treatment of liver cancer. Dr. Abou-Alfa serves as the chair of the National Cancer Institute (NCI) Task Force for Hepatobiliary Cancers, the chair of the AIDS Malignancy Consortium (AMC) Non-AIDS Defining Malignancies (NADC) Liver/GI Task Force and is the President-Elect for the International Society of Gastrointestinal Oncology. Dr. Abou-Alfa has lectured worldwide on the subject on liver cancer. He serves as the chair of the medical/scientific boards of Blue Faery and the Cholangiocarcinoma Foundation, and also serves on the National Medical Advisory Committee of the American Liver Foundation.