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USPTO issues can-fite patent for CF102 to treat liver regeneration and function after surgery

Can-Fite BioPharma, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, has announced the US Patent and Trademark Office has issued a patent to the Company which covers its drug candidate, CF102, in the treatment of liver regeneration and function following liver surgery.

The issued patent # 8,846,635 is titled, "Method for inducing hepatocyte proliferation and uses thereof." Can-Fite has recently been granted a patent for this technology in Japan and the European Union.

CF102 is now entering Phase II trials for the treatment of hepatocellular carcinoma, the most common form of liver cancer in the U.S., Europe and Israel.

The US Food and Drug Administration has granted Orphan Drug Status to Can-Fite’s CF102 for this indication and Israel’s Ministry of Health has approved CF102 for Compassionate Use in liver cancer.

"The treatment of post-surgery liver function is an indication that would complement our current portfolio of indications in clinical trials. CF102 may offer important healing benefits for the liver not only to cancer patients, but also for patients who have other diseases or injuries of the liver," stated Can-Fite CEO Pnina Fishman.

In preclinical studies, CF102 has induced proliferation of hepatocytes following liver resection (surgery), increased liver weight and reduced 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.

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 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 U.S., Israel, and Europe. The U.S. 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.