U.S. FDA Agreed with Can-Fite’s
Proposed Pivotal Phase III Trial Design to Support
a New Drug Application Submission and Approval of Namodenoson in
the Treatment of Liver Cancer
Successful conclusion of an End of Phase II meeting with the FDA
PETACH TIKVA, Israel, October 31, 2019 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today it has concluded an End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA) regarding its recently completed Phase II study of Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer. The purpose of the meeting was to review the Phase II study data with the FDA and to present Can-Fite’s proposed Phase III study design to the regulatory agency.
The FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application (NDA) submission and approval. The Phase III study will enroll patients with advanced HCC, with underlying Child Pugh B7 (CPB7) cirrhosis, whose cancer has progressed on first line therapy. This design leverages the previously announced Phase II trial data, which showed promising efficacy signals in this population. The FDA’s guidance will be incorporated into the Phase III study’s final protocol.
“Namodenoson is a novel approach to treating advanced liver cancer with an orally bioavailable drug specifically targeting the tumor cells, a unique mechanism that contributes to the favorable safety profile. We are very pleased with this outcome from our meeting with the FDA. With the FDA’s guidance, we plan to now finalize our Phase III study protocol for this unmet advanced liver cancer indication,” stated Dr. Michael Silverman, Can-Fite’s Medical Director.
Can-Fite’s completed Phase II liver cancer study found that Namodenoson increased overall survival in HCC patients with CPB7 cirrhosis, the largest subpopulation of the study, even though the Phase II study did not achieve its primary endpoint of overall survival in the whole population.
DelveInsight estimates the HCC drug market will reach $3.8 billion in 2027 in the G8 countries. According to the American Cancer Society, in the U.S. liver cancer incidence has tripled since 1980, with an estimated 42,000 cases diagnosed and 32,000 deaths annually. Incidence of liver cancer is much higher in other countries, with more than 800,000 diagnoses and 700,000 deaths estimated globally each year.
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being developed as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial 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, inflammatory disease and sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and is in a Phase II 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 in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.
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