CF102 drug-Fite Can gets approval in Israel for the patient with hepatocellular carcinoma -
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a proprietary drug pipeline to small molecules that target inflammatory diseases and cancer, today announced that the Israeli Ministry of Health (MOH) approved the use of its CF102 drug for a patient with hepatocellular carcinoma, the most common form of liver cancer, under the Compassionate use Program in the country. The program allows physician to the unique initiative of access of patients to experimental treatments for innovative products or research not yet registered in any country in the world. Can Fite has also previously received orphan drug designation from the Food and Drug Administration of the United States for CF102 in the treatment of advanced hepatocellular carcinoma.
This patient was previously enrolled in the phase of Can-Fite I / II dose-escalation study of liver cancer in Israel and was 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 disease in 22% of patients, prolonged survival time compared to placebo and regression tumor metastasis skin.
on the basis of these encouraging results, Can-Fite began a comprehensive phase II trial for CF102 as a second-line treatment of advanced hepatocellular carcinoma (HCC) with Class Child-Pugh B cirrhosis patients who have failed Nexavar (sorafenib), which is FDA-approved drug for the treatment of hepatocellular carcinoma. The phase II study will be conducted in the United States, Europe and Israel with 78 subjects to be dosed with CF102. The study protocol was approved by Israel and the United States, and approval is expected from the European Union.
According to Global Industry Analysts, the global cancer liver drug market is expected to exceed $ 2 billion by 2015.
"We are so pleased that the Ministry of Health given the continued use of CF102 in the Program on the use of compassion for this patient who seems to have benefited greatly from our drug. Before enrolling in our Phase I / II study, patients had undergone all other treatments approved and they managed to stop the progression of the disease. we are told by his doctor that he is strong and stable health and we wish her well being, "said 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 decision of the Ministry of Health to approve CF102 for compassionate use."
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