Petah-Tikva, Israel -- (SBWire) -- 07/22/2014 --Can-Fite BioPharma Ltd, a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that the Israeli Ministry of Health (MOH) has approved the use of its drug CF102 for a patient with hepatocellular carcinoma, the most common form of liver cancer, under the country's Compassionate Use Program. The program allows doctor-initiated single-patient access to investigational treatments for innovative or investigational products not yet registered in any country worldwide. Can-Fite has also previously received Orphan Drug Designation from the U.S. Food and Drug Administration for CF102 in the treatment of advanced hepatocellular carcinoma.
This patient was previously enrolled in Can-Fite's Phase I/II dose escalating liver cancer study in Israel and has been successfully treated with CF102 for about 5 years. Data from the completed Phase I/II study demonstrated a very favorable safety profile, lack of hepatotoxicity, stabilization of the disease in 22% of patients, prolonged survival time as compared to placebo and regression of skin tumor metastases.
Based on these encouraging results, Can-Fite has begun a global Phase II trial for CF102 as a second-line treatment of advanced hepatocellular carcinoma (HCC) with Child-Pugh Class B cirrhosis in patients who have failed Nexavar (sorafenib) which is the only FDA approved drug for the treatment of hepatocellular carcinoma. The Phase II study will be conducted in the U.S., Europe, and Israel with 78 subjects who will be dosed with CF102. The study protocol has been approved in Israel and the U.S. , and approval is expected from the Europe Union.
According to Global Industry Analysts, the global liver cancer drug market is expected to exceed $2 billion by 2015.
"We are so pleased the Ministry of Health has granted continued use of CF102 under the Compassionate Use Program for this patient who appears to have benefitted greatly from our drug. Prior to enrolling in our Phase I/II study, the patient had undergone all other approved treatments and they had failed to halt the progression of the disease. We are told by his doctor that he is in strong and stable health and we wish him continued wellbeing," stated Can-Fite CEO Dr. Pnina Fishman. "We believe that the very favorable safety data from our Phase I/II trial may have been a key factor in the MOH's decision to approve CF102 for compassionate use."
About CF102
CF102 is a small orally bioavailable drug which binds with high affinity and selectivity to the A3 adenosine receptor. The latter 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 our pre-clinical and clinical studies, CF102 induces a robust anti-tumor effect via de-regulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. 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:http://canfite.co.il/
Forward-Looking Statements
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Can-Fite's CF102 Approved for Compassionate Use in Israel for Liver Cancer Patient
Patient was previously enrolled in Can-Fite's Phase I/II liver cancer study and has survived for about 5-years using the Company's cancer drug; The global liver cancer drug market is expected to exceed $2 billion by 2015