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Preclinical Data Show Can-Fite's Namodenoson (CF102) Prevents Progression of Liver Fibrosis
- Phase II trial to treat NAFLD/NASH expected to commence in 2017
liver fat content and fibrosis are the main unmet needs in NASH, according to KOL Dr. Rifaat Safadi
TIKVA, Israel, February. 28, 2017 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company advancing a
pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced new data that
show its liver disease drug candidate Namodenoson (CF102) prevented liver (hepatic) fibrosis progression in preclinical studies.
latest study results add to the growing body of data that demonstrate Namodenoson's potential efficacy in combating non-alcoholic
fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH), indications for which there is currently no
FDA approved drug. We are advancing Namodenoson into a Phase II trial in NAFLD and expect to commence patient enrollment in the
coming months through leading medical institutions in Israel," stated Can-Fite CEO Dr. Pnina Fishman.
fibrosis is the excessive accumulation of scar tissue resulting from ongoing inflammation. It can result in diminished blood flow
throughout the liver and is associated with NAFLD.
preclinical studies in a mouse model of liver fibrosis demonstrated the anti-fibrotic effects of Namodenoson. The Namodenoson
treated group exhibited normal liver under macroscopic view, no accumulation of fluid (ascites), a low fibrosis profile, and lower
serum levels of transaminases as compared to the control group. In addition, liver protein extracts and mRNA for the alpha smooth
muscle actin showed a significant anti-fibrotic effect in the Namodenoson treated group as compared to the control group.
studies were conducted by a third party 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
Safadi commented, "Lowering liver fat content and fibrosis are the main unmet needs in NASH. Today there is a huge market
need for drugs that fight the worldwide NASH epidemic."
is uniquely compelling for its potential to treat NAFLD and NASH because its safety profile has already been de-risked, increasing
the likelihood it can advance through late stage trials and into clinical use for this large and unmet need," Dr. Safadi
added. "In general, there is significant development risk for new potential drugs in development due to safety risks including
drug induced liver injury (DILI), drug-to-drug interactions (DDI), and metabolites in safety testing (MIST). Namodenoson, however,
has demonstrated a good safety profile and is low or negative for DILI, DDI and MIST."
addition, Namodenoson 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," concluded Dr. Safadi.
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 2017 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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