Full Press Release Details
Medicines Agency Grants Orphan Designation to Can-Fite's
CF102 in the Treatment of Liver Cancer
10-year market exclusivity
in Europe following marketing authorization in 31
European Economic Area (EEA) countries
PETACH TIKVA, Israel, October 12, 2015
-- Can-Fite BioPharma Ltd. (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 Company's oncology drug candidate, CF102, has been
granted Orphan Drug Designation by the European Medicines Agency (EMA) for the indication of hepatocellular carcinoma (HCC),
the most common form of liver cancer.
CF102 will benefit from protocol assistance
and a 10-year market exclusivity following market authorization in the 28 European Union (EU) Member states, as well as 3 additional
European Economic Area (EEA) countries.
"The EMA's Orphan Drug
designation for CF102 is the latest in a series of catalysts that we believe are accelerating the clinical development path of
our liver cancer drug towards market approval. As we actively recruit patients in our Phase II study of CF102 in Europe, we are
pleased the EMA will support CF102 through protocol assistance and post-authorization market exclusivity," stated Can-Fite
CEO Dr. Pnina Fishman.
In the U.S., CF102 has already
received Fast Track Designation as a second line for the treatment of HCC of patients who have previously received Nexavar (sorafenib)
and Orphan Drug Designation for the treatment of HCC. Israel's Ministry of Health has also approved CF102 for Compassionate
Can-Fite is conducting a Phase
II study with CF102 in patients with advanced HCC in the U.S., Europe and Israel. 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.
According to Global Industry Analysts,
the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar annual sales, as reported by Bayer,
were 773 million in 2014.
CF102 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.
About Can-Fite BioPharma Ltd.
Can-Fite 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 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. 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.
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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
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to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.