Can-Fite to Initiate a Phase II Study With CF102 in 130 Patients With Advanced Liver Cancer
August 28 2013 - 11:12AM
Marketwired
Can-Fite BioPharma (TASE: CFBI) (PINKSHEETS:
CANFY), a biotechnology company with a pipeline of proprietary
small molecule drugs that address inflammatory and cancer diseases,
announced today that it will initiate a its Phase 2 study in the
U.S., Europe and Israel for its anti-cancer drug CF102 in the
treatment of primary liver cancer (hepatocellular carcinoma, or
HCC). CF102 is the second drug in the Company's pipeline of A3
adenosine receptor ligands.
Based on the successful conclusion of a former Phase 1/2 trial,
the Company developed a Phase 2 protocol that will be conducted
under an open Investigational New Drug (IND) with the U.S. Food and
Drug Administration. CF102 has Orphan Drug Designation from the FDA
for the treatment of hepatocellular carcinoma (primary liver
cancer).The study will include 130 patients with advanced liver
cancer, with CF102 given as a standalone drug.
According to Global Industry Analysts, the global liver cancer
drug market is expected to exceed $2 billion by 2015.
Data from the Phase 1/2 study were published recently in The
Oncologist, one of the leading journals in this field, and will be
presented in the 18th World Congress on Advances in Oncology. The
Company reported that the Phase 1/2 study data demonstrated that
the trial objectives were successfully achieved, demonstrating a
very favorable safety profile for CF102 in a patient population
with hepatocellular carcinoma and Child-Pugh cirrhosis classes A
and B. In addition, the median overall survival time was very
encouraging given that most patients were treated in the
second-line setting and some were Child-Pugh class B. Another
finding indicated that the A3 adenosine receptor, which is the
target of CF102, can serve as a biomarker to predict the patients'
reaction to treatment with CF102. Interestingly, one of the
patients that has been included in the Phase 1/2 study is treated
for 4 years with CF102 and is doing very well.
About CF102
CF102 is a small orally bioavailable drug which binds with high
affinity and selectivity to the A3 adenosine receptor. The latter
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. CF102 induces a robust
anti-tumor effect via de-regulation of the Wnt signaling pathway,
resulting in apoptosis of liver cancer cells.
About Can-Fite Biopharma Ltd.
Can-Fite Biopharma Ltd is an Israeli public company, the
ordinary shares of which are traded on the Tel Aviv Stock Exchange
(TASE: CFBI). American Depository Receipts of the company are
traded on the over-the-counter market (PINKSHEETS: CANFY). The
company, which commenced business activity in 2000, was founded by
Pnina Fishman, Ph.D., researcher in the Rabin Medical Center, and
Ilan Cohn Ph.D., patent attorney and senior partner at Reinhold
Cohn Patent Attorneys. Pnina Fishman serves as CEO of the company.
The company was founded on the basis of Fishman's scientific
findings, and is focused on the development of small molecule
orally bioavailable drugs, ligands to the A3 adenosine receptor.
The latter mediates anti-inflammatory and anti-cancer effects and
is suggested as a biological predictive marker. The company's lead
drug, CF101, is in clinical development for the treatment of
autoimmune inflammatory diseases. The CF102 drug candidate is being
developed for the treatment of liver diseases. Can-Fite has a
wealth of clinical experience: to date, more than 700 patients have
participated in clinical trials conducted by the company. Can-Fite
previously licensed its activity in the ophthalmic field to
OphthaliX Inc., in which it holds a controlling interest.
Safe Harbor Statement
Any statements in this press release that relate to the
Company's expectations are forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act. The
Private Securities Litigation Reform Act of 1995 (PSLRA)
implemented several significant substantive changes affecting
certain cases brought under the federal securities laws, including
changes related to pleading, discovery, liability, class
representation and awards fees. Since this information may involve
risks and uncertainties and are subject to change at any time, the
Company's actual results may differ materially from expected
results. Additional risks associated with Can-Fite's business can
be found in its periodic filings with the Tel Aviv Stock
Exchange.
Add to Digg Bookmark with del.icio.us Add to Newsvine
Contact: IRTH Communications Robert Haag Email Contact
1-866-976-IRTH (4784)