Full Press Release Details
Establishes Clinical Advisory Board for NAFLD/NASH
TIKVA, Israel, June 5, 2017 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline
of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced it has established a
Clinical Advisory Board comprised of experts in the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis
(NASH). The Board's role is to provide advice and steer the clinical development program of Can-Fite's drug candidate
Namodenoson (CF102) in the treatment of NAFLD and NASH. A Phase II trial of Namodenoson in the treatment of NAFLD/NASH is expected
to commence patient enrollment during the third quarter of 2017.
Advisory Board members include:
Scott Friedman: Dr. Friedman is the Dean for Therapeutic Discovery and Chief of the Division of Liver Diseases at the Icahn
School of Medicine at Mount Sinai in New York. He also serves as a Professor of Medicine, Liver Diseases and Professor of Pharmacological
Studies. He has performed pioneering research into the underlying causes of scarring, or fibrosis associated with chronic liver
disease, affecting millions worldwide. Dr. Friedman was among the first to isolate and characterize the hepatic stellate cell,
the key cell type responsible for scar production in liver. His work has spawned an entire field that is now realizing its translational
and therapeutic potential, with new anti-fibrotic therapies for liver disease reaching clinical trials.
Arun Sanyal: Dr. Sanyal is a Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University
School of Medicine. He has over 25 years of experience as a hepatologist and has served as the secretary and president of the
American Association for Study of Liver Diseases, founding member of the Hepatology board of the American Board of Internal Medicine,
and chair of the NIH hepatobiliary pathophysiology study section and member of the council of the NIH. Dr. Sanyal's research
spans two major areas including cirrhosis and its complications; and alcoholic- and nonalcoholic steatohepatitis (NASH). Recently,
he has helped establish and chair the "Liver Forum" which brings FDA, European Medical Agency, Academia, NIH and industry
stakeholders in NASH and hepatic fibrosis together to accelerate therapeutic development in these areas.
Rifaat Safadi: Dr. Safadi is Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah
Medical Center and Professor of Internal Medicine, Bowel, Liver Disease, and Metabolic Syndrome at Hadassah University in Israel.
Hadassah is one of the clinical sites where Can-Fite has received Institutional Review Board (IRB) approval to conduct its Phase
II trial of Namodenoson in the treatment of NAFLD/NASH. Dr. Safadi has previously supervised preclinical studies of Namodenoson
at Hadassah. Dr. Safadi's areas of expertise include liver and bowel diseases and metabolic syndrome. He is a member of
the American Gastroenterology Association, the American Association for the Study of Liver Diseases, the European Association
for the Study of the Liver, the Israeli Transplantation Society, the Israel Association for the Study of the Liver, and the Israel
Association for Gastroenterology & Hepatology.
are honored to have these three distinguished Key Opinion Leaders in the field of liver disease join our newly established NAFLD/NASH
Clinical Advisory Board. We believe Can-Fite will benefit from their collective experience both as researchers and as medical
practitioners in treatment of NASH," stated Can-Fite CEO Dr. Pnina Fishman.
is characterized by excess fat accumulation in the form of triglycerides (steatosis) in the liver. According to a study published
in Hepatology, an estimated 17%-33% of the population in the U.S. has NAFLD, with a higher prevalence in people with type II diabetes.
Incidence is increasing based on rising obesity rates. NAFLD includes a range of liver diseases, with NASH being the more advanced
form, manifesting as hepatic injury and inflammation. According to the NIH, the incidence of NASH in the U.S. is believed to affect
2-5% of the population. The spectrum of NAFLDs resembles alcoholic liver disease; however, they occur in people who drink little
or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer. By 2025, the addressable pharmaceutical market for NASH
is estimated to reach $35-40 billion.
is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is
highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the
excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, Namodenoson has demonstrated a robust anti-tumor
effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells. Based on preclinical data
showing Namodenoson has strong liver protective properties, Can-Fite intends to initiate a Phase II study in NASH. Can-Fite has
received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second
line treatment for hepatocellular carcinoma.
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology
that is designed to address multi-billion dollar markets in the treatment of autoimmune-inflammatory indications, oncology and
liver diseases as well as sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is headed into Phase III trials
for two indications, rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug Namodenoson is in a Phase II trial for patients
with liver cancer and is slated to enter another Phase II for the treatment of non-alcoholic fatty liver disease (NAFLD), the
precursor to non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe
and Fast Track Designation as a second line treatment for hepatocellular carcinoma by the U.S. Food and Drug Administration. Namodenoson
has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's
third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies These drugs have an excellent
safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.
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