(NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline
of proprietary small molecule drugs that address inflammatory and cancer
diseases, today announced the U.S. Food and Drug Administration (FDA)
has granted the Company’s drug candidate CF102 Fast Track designation as
a second line treatment for hepatocellular carcinoma (HCC), the most
common form of liver cancer. CF102 had already received the FDA’s Orphan
The randomized, double blind, placebo controlled study is expected to
complete enrollment by the end of the first half of 2016 in 78 patients
with Child-Pugh Class B cirrhosis who failed the only FDA approved drug
on the market, Nexavar® (sorafenib). Patients are treated twice daily
with 25 mg of oral CF102, which has been found to be the most
efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the
longest overall survival time, with excellent safety results.
aimed at getting important new drugs that meet an unmet need to
patients earlier, is expected to expedite the development of CF102.
Drugs that receive Fast Track designation benefit from more frequent
meetings and communications with the FDA to review the drug’s
development plan to support approval. It also allows the Company to
submit parts of the New Drug Application (NDA) on a rolling basis for
review as data becomes available. Since the Fast Track Program started,
from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.
are very pleased that the FDA recognizes the potential for CF102 to
treat HCC patients who have tried, and not been responsive to Nexavar,
the only FDA approved drug currently on the market for this indication,”
stated Can-Fite CEO Dr. Pnina Fishman.
“We consider Fast Track designation to be a major catalyst for our
CF102 development program and we believe it could shorten our time to
market for CF102, thereby making a considerable difference for
is a small orally bioavailable drug that binds with high affinity and
selectivity to the A3 adenosine receptor (A3AR). A3AR is highly
expressed in tumor 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,
CF102 has demonstrated a robust anti-tumor effect via deregulation of
the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.
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 is
preparing for a Phase III CF101 trial for rheumatoid arthritis and is
preparing its protocol for its next advanced psoriasis clinical trial.
Can-Fite’s liver cancer drug CF102 is in Phase II trials and has been
granted Orphan Drug Designation and Fast Track Designation by the U.S.
Food and Drug Administration. CF102 has also shown proof of concept to
potentially treat other cancers including colon, prostate, and melanoma.
The Company’s CF602 has shown efficacy in the treatment of erectile
dysfunction. Can-Fite has initiated a full pre-clinical program for
CF602 in preparation for filing an IND with the U.S. FDA in this
indication. These drugs have an excellent safety profile with experience
in over 1,200 patients in clinical studies to date. For more
information please visit: www.can-fite.com.