Full Press Release Details
Preclinical Data Show Can-Fite's Namodenoson (CF102) Inhibits Liver Fibrosis
- Supports Potential Efficacy in Treatment
II trial to treat NAFLD/NASH expected to commence in 2017
TIKVA, Israel, December 16, 2016 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with
a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction,
today announced that new preclinical data show its liver disease drug candidate Namodenoson (CF102) inhibited, in a dose dependent
manner, the growth and proliferation of the liver fibrosis cells. This outcome suggests the anti-fibrotic effect of the drug and
supports its development as an agent to combat non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis
studies which evaluated the effects of Namodenoson on fibrogenic hepatic stellate cells were conducted under the supervision of
Prof. Rifaat Safadi M.D., a Key Opinion Leader in the field of liver diseases, and Director of Liver Unit, Institute of Gastroenterology
and Liver Diseases, Hadassah University Hospital, Ein Kerem.
Safadi commented, "Today there is a huge market need for drugs that fight the worldwide NASH epidemic. Lowering liver fat
content and fibrosis are the main unmet needs in NASH. This is especially so for a drug candidate with the profile of Namodenoson,
which recognizes the difference between diseased and normal cells, and targets only the diseased cells through the specific A3
adenosine receptor. This precision targeting is designed to lead to higher efficacy and safety by leaving healthy cells unaffected.
We are all looking for drugs with this profile to treat NASH."
latest study results add to the growing body of data that demonstrate Namodenoson's potential efficacy in NAFLD and NASH,
indications for which there is currently no FDA approved drug. We are advancing Namodenoson into a Phase II trial that we expect
to commence in the coming months through leading medical institutions in Israel," stated Can-Fite CEO Dr. Pnina Fishman.
2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.
is characterized by excess fat accumulation in the form of triglycerides (steatosis) in the liver. According to a recent study
published in Hepatology, an estimated 25% 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.
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 cancer, inflammatory disease and sexual dysfunction.
The Company's lead drug candidate, Piclidenoson, is scheduled to enter Phase III trials in 2016 for two indications, rheumatoid
arthritis and psoriasis. The rheumatoid arthritis Phase III protocol has recently been agreed with the European Medicines Agency.
Can-Fite's liver cancer drug Namodenoson is in Phase II trials for patients with liver cancer and is slated to enter Phase II
for the treatment of 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 and is
being prepared for an IND submission to the FDA and a Phase I trial. 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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