Results indicate Namodenoson has a good safety profile and is well tolerated in patients under compassionate use
Two patients from the former Phase II study are still undergoing treatment of Namodenoson, each with an overall survival of >2.5 years
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today it has already enrolled seven patients for the compassionate use program for Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer. Results of treatment in this patient group indicate that Namodenoson was found to have a good safety profile and was well tolerated, with no severe adverse events reported. Can-Fite’s compassionate use program is managed by Dr. Salomon Stemmer, a key opinion leader in the field of liver cancer, and Professor at the Institute of Oncology, Rabin Medical Center, Israel.
The Company also reports that an additional two patients from the former Phase II study are still undergoing Namodenoson treatment, each with an overall survival of more than 2.5 years.
Recently, the Company successfully concluded an End-of-Phase II meeting with the FDA which agreed with Can-Fite’s proposed pivotal Phase III trial design of Namodenoson for the treatment of patients with advanced HCC, with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. In addition, the Company also submitted a Phase III protocol and Registration Plan to the European Medicines Agency (EMA) for Namodenoson and expects to receive a response from the EMA in the next few weeks. Can-Fite plans to work concurrently with the two agencies, the FDA and EMA, with the expectation to register the drug in parallel upon successful conclusion of the Phase III study.
"We are grateful to Dr. Stemmer for leading this compassionate use program, making Namodenoson available to patients who have exhausted all other treatment options. Based on the encouraging results of our recent Phase II trial, in which Namodenoson demonstrated clinical benefits in patients with underlying CPB7 cirrhosis, Can-Fite is committed to providing Namodenoson to fulfill the unmet medical need in this population," stated Can-Fite CEO Dr. Pnina Fishman.
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated 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. 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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