Exhibit 99.1
Can-Fite Issued Japanese Patent for CF102 in the Treatment of Liver Regeneration and Function Following Surgery
In preclinical studies, CF102 induces hepatocyte proliferation resulting in improved liver status
PETACH TIKVA, Israel, September 5, 2014 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today 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.
About CF102
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.
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 and inflammatory diseases. The Company’s CF101 is in Phase II/III trials for the treatment of psoriasis and the Company is preparing for a Phase III CF101 trial for rheumatoid arthritis. Can-Fite’s liver cancer drug CF102 is commencing Phase II trials and has been granted Orphan Drug Designation 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. 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
Forward-Looking Statements
This press release may contain 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 representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite's authorized executive officers. 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 by the forward-looking statements. Many factors could cause Can-Fite's actual activities or results to differ materially from 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.
Contact:
Can-Fite BioPharma
Motti Farbstein
+972-3-9241114