Broad patent addresses markets for the treatment of all advanced liver fibrosis indications
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office (PTO) for its invention titled “Method for Treating Fibrotic Liver Tissue Using CL-IB MECA”.
Currently, Namodenoson (CL-IB-MECA) is being developed for two liver indications, liver cancer and NASH. The allowance granted by the US PTO opens the door for much broader market needs which entail all clinical conditions with advanced liver fibrosis including autoimmune hepatitis, primary biliary cirrhosis (PBC), nonalcoholic fatty liver disease (NAFLD), and alcoholic liver disease (ALD) among others. The global liver disease treatment market was valued at approximately $20 billion in 2020 by Allied Market Research.
Can-Fite is currently enrolling patients in a Phase IIb trial of Namodenoson for the treatment of NASH, an advanced non-alcoholic fatty liver disease, for which there is no U.S. FDA approved treatment. Additionally, the Company expects to commence enrollment in a pivotal Phase III study of Namodenoson in the treatment of advanced liver cancer (hepatocellular carcinoma CPB7).
Can-Fite’s robust IP portfolio includes patents that address NASH and liver cancer, issued in approximately 40 countries. Namodenoson has been out-licensed in select countries for the treatment of NASH and liver cancer with agreements that include upfront and milestone payments.
“This U.S. patent is a very important addition to our growing IP portfolio in liver diseases. It is very well timed with our Phase IIb NASH study and Phase III liver cancer trial. Both are high value indications in which our robust patent portfolio and Namodenoson’s safety and efficacy profile position Can-Fite for potential additional strategic distribution deals worldwide,” stated Can-Fite CEO Dr. Pnina Fishman.
There is currently no U.S. FDA approved treatment for NASH, an addressable pharmaceutical market estimated to reach $35-$40 billion by 2025 driven by increasing incidence. The U.S. National Institutes of Health estimate the prevalence of NASH in the U.S. at 2-5% of the population. NASH is the leading cause for liver transplants among women and second leading cause overall in the U.S. Given the rate of increase, it is expected to become the leading indication for liver transplants in males as well.
Hepatocellular carcinoma (HCC) is the most common form of liver cancer. HCC with underlying Child Pugh B7 (CPB7) is one of the most advanced forms of liver cancer. More than 800,000 people are diagnosed with liver cancer annually and approximately 700,000 die of the disease each year, according to the American Cancer Society. The HCC drug market is projected to reach $3.8 billion by 2027.
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: 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, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.
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