Can-Fite's CF102 drug gets approval in Israel for patient with hepatocellular carcinoma

NewsGuard 100/100 Score

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), 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."


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
NCCN 2024 Annual Conference focuses on practical applications for improving cancer care