Full Press Release Details
Reports Positive Top Line Results from its Phase II NASH Study with Namodenoson
TIKVA, Israel, April 7, 2020 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a
pipeline of proprietary small molecule drugs that address inflammatory and liver diseases, today announced that its Phase II exploratory
NAFLD/NASH study with Namodenoson achieved its efficacy endpoints, while continuing to demonstrate a good safety profile.
Phase II double-blind, placebo-controlled, dose-finding efficacy and safety study enrolled 60 patients with non-alcoholic fatty
liver disease (NAFLD) with or without non-alcoholic steatohepatitis (NASH) in three clinical sites in Israel including Hadassah
Medical Center, Jerusalem; Rabin Medical Center, Petach Tikva; and Holy Family Hospital, Nazareth; with Prof. Rifaat Safadi as
the Principal Investigator. Patients with evidence of an active inflammation were treated twice daily with 12.5 mg (n=21) or 25
mg (n=19) of oral Namodenoson vs. placebo (n=20). The patients were treated for 12 weeks and followed-up until week 16. The study's
end points included among others alanine aminotransferase (ALT) and aspartate aminotransferase (AST) blood level, % of liver fat,
liver stiffness, serum adiponectin, leptin and patient's weight loss.
significant positive data and trends were found as follows:
Rifaat Safadi commented, "We are very pleased with the outcome of this study which shows clear efficacy and safety. One
of the goals of this study was to determine the optimal dosage, and we have achieved that, as it appears from the data that 25
mg is both safe and most effective. Namodenoson is a very strong candidate for continued clinical development in the treatment
of NAFLD/NASH, particularly since no other treatment options are approved for this specific and growing unmet need."
CEO Dr. Pnina Fishman stated, "The data indicate Namodenoson's robust anti-NAFLD/NASH effects. We are very pleased
that the patients benefitted from treatment and we look forward to advancing this into the next phase of clinical development.
NASH market is estimated to reach $35-40 billion by 2025.
is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson
was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment
for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). 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.
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE American: 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 currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's
liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of
liver cancer, and is in a Phase II trial 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 HCC 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. These drugs
have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please
visit: www.can-fite.com.
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