5 November 2019 - - Israel-based biotechnology company Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) has initiated its compassionate use programme for Namodenoson in the treatment of hepatocellular cancer, the most common form of liver cancer, the company said.
Can-Fite's compassionate use program has enrolled and started treating patients.
The compassionate use programme, which enables liver cancer patients not enrolled in Can-Fite's clinical study to be treated with Namodenoson, is being administered by Dr. Salomon Stemmer, the principal investigator of the company's prior Phase II liver cancer study, and Professor at the Institute of Oncology, Rabin Medical Center, Israel.
Compassionate use allows doctors and their patients the option of early access to investigational new drugs, under closely controlled and monitored circumstances, when a patient who is facing serious illness has exhausted all available treatment options.
Can-Fite's completed Phase II liver cancer study found that Namodenoson increased overall survival in HCC patients with Child Pugh B7, the largest subpopulation of the study, as compared to placebo, even though the trial did not meet its primary endpoint.
The company recently completed a successful End-of-Phase II meeting with the US Food and Drug Administration, in which the 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 HCC.
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor. 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. 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.
Can-Fite BioPharma is an advanced clinical stage drug development company with a platform technology that is designed to address multi-bn 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, the most common form of liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis.
Namodenoson has been granted Orphan Drug Designation in the US and Europe and Fast Track Designation as a second line treatment for HCC by the US 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.