Full Press Release Details
Phase II Study Protocol to Treat Patients with Advanced Liver Cancer with CF102 has been Approved by the IRB in Israel
CF102 has Orphan Drug Designation
Global Liver Cancer Drug Market is Expected
to Exceed $2 Billion by 2015
Petach Tikva, Israel, March 17, 2014:
Can-Fite BioPharma (TASE: CFBI), (NYSE MKT:CANF), a biotechnology company with a pipeline of
proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that a Phase II study protocol
for the treatment of advanced liver cancer with its CF102 has been approved by the Institutional Review Board (IRB) in Israel.
plans to conduct the Phase II study in Israel, Europe and the US and it will include 78 subjects that will be dosed with
the drug as a second-line treatment of advanced hepatocellular
carcinoma with Child-Pugh Class B cirrhosis. The study will investigate the efficacy and safety of CF102 vs. placebo. The protocol
has been approved by the IRB at the Rabin Medical Center, Petach Tikva, and the company intends to follow up with European and
US submissions shortly. The study protocol was developed with the assistance of Dr. Keith Stuart, MD, Chairman, Department of Hematology
and Oncology Professor of Medicine, Tufts University School of Medicine a well-known internationally expert in Liver Cancer. This
center will also participate in the study.
and Drug Administration (FDA) has granted Orphan Drug designation for CF102, for the treatment of hepatocellular carcinoma.
FDA orphan drug status grants various incentives for developing these drugs, including shortened
approval procedures, tax breaks on R&D costs, and financing assistance. If the drug is the first to reach market, it also receives
seven years exclusivity.
According to Global Industry Analysts,
the global liver cancer drug market is expected to exceed $2 billion by 2015.
The company reported earlier that data
from the Phase I/II study were published recently in The Oncologist, one of the leading journals in this field,
and was presented at the 18th World Congress on Advances in Oncology. The company reported that the Phase I/II 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 included in the Phase I/II study has been treated for 4 years with
CF102 and is continuing to be treated, with 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. In our
pre-clinical and clinical studies, 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 (the "TASE") (TASE: CFBI). Level II American
Depository Receipts of the Company currently trade on the NYSE MKT (NYSE MKT: CANF). Can-Fite, 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 in Israel. Dr. Fishman serves as the Chief Executive Officer of Can-Fite. Dr.
Fishman founded Can-Fite on the basis of her scientific findings, and Can-Fite is focused on the development of small molecule
orally bioavailable drugs, in particular, ligands that bind to the A3 adenosine receptor. Such drugs mediate anti-inflammatory
and anti-cancer effects and the A3AR is developed as a biological predictive marker. Can-Fite's lead drug candidate, CF101, is
in clinical development for the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis. Can-Fite's
CF102 drug candidate is being developed for the treatment of liver diseases and CF602 is being developed for the treatment of inflammation
and sexual dysfunction. To date, more than 1000 patients have participated in clinical trials
conducted by Can-Fite. Can-Fite previously spun off it's activity in the ophthalmic field to OphthaliX Inc., in which it
holds 82%, and is currently listed on the U.S. Over-the-Counter Markets (OTCQB: OPLI).
IRTH Communications, LLC
Forward-Looking Statements
This press release contains forward-looking
statements, about Can-Fite's expectations, beliefs or intentions regarding, among other things, its product development efforts,
business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its
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Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made.
Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks
and uncertainties that could cause Can-Fite's actual results to differ materially from any future results expressed or implied
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the activities and results anticipated in such forward-looking statements, including, but not limited to, the factors summarized
in Can-Fite's filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector
where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does
not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future
events or otherwise.