Can-Fite BioPharma Ltd. (CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, announced the issuance of Patent No. 2010-529501, titled, "Method for inducing hepatocyte proliferation and uses thereof," by the Japanese Patent Office.

The patent covers Can-Fite's clinical stage drug candidate, CF102, in the treatment of liver regeneration and function following liver surgery or other injury via inhibition of pro-apoptotic proteins, resulting in liver repair. A European Patent (No. 2227234) for this technology was issued earlier this year in the European Union.

"This patent further expands our worldwide patent portfolio," stated Dr. Pnina Fishman, CEO of Can-Fite. "In preclinical studies, CF102 induces proliferation of hepatocytes following liver resection (surgery), increases liver weight and reduces elevated levels of serum liver enzymes, reflecting improved liver status. In patients with preexisting liver diseases, such as cirrhosis or cancer, normal hepatocellular proliferation following injury is impaired, exposing patients to liver dysfunction and associated complications that can lead to liver failure and death. We believe that the use of CF102 to induce proliferation of hepatocytes in liver cancer patients following surgery may provide important health benefits and prolong survival."

Can-Fite currently has an out-licensing agreement with Seikagaku Corporation, which has licensed the rights to develop Can-Fite's investigational drug candidate, CF101, for the treatment of autoimmune inflammatory indications in Japan. The agreement is worth up to $20 million in upfront, milestone and annual payments for Can-Fite, plus up to 12% in royalties. Can-Fite has received $7.5 million to date.

Can-Fite's intellectual property portfolio consists of 150 issued and pending patents worldwide. Additional patents relating to induction of hepatocyte proliferation and uses thereof are pending in several other markets, including the United States and Israel.

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. CF102 is in phase II clinical trials for the treatment of liver cancer in the US, Israel, and Europe.  The US Food and Drug Administration has agreed with Can-Fite's phase II study protocol and had previously granted Can-Fite Orphan Drug Designation for CF102 in the treatment of hepatocellular carcinoma, the most common form of liver cancer.

Can-Fite BioPharma Ltd. 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 and inflammatory diseases.