Positive results from Can-Fite BioPharma's CF102 Phase 1/2 study on HCC

Jan 4 2012

Can-Fite BioPharma Ltd (TASE:CFBI), a biotechnology company developing small molecule drugs for the treatment of inflammatory, and liver diseases, traded on the Tel Aviv Stock Exchange announced today the successful results of the Phase 1/2 study of its drug candidate CF102 in the treatment of hepatocellular carcinoma (HCC). Source: Can-Fite BioPharma Ltd

The company also announced today that a separate phase 1/2 study in patients with Hepatitis C (HCV) reached the study's main objectives of safety and pharmacokinetic behavior.

The HCC study which was conducted under the supervision of Dr. Salomon M. Stemmer, Institute of Oncology, Davidoff Center, Rabin Medical Center, included 18 patients with HCC, most of them had failed prior treatment with Sorafenib (Nexavar), the only currently approved drug for this indication. The primary study objectives were to evaluate the safety profile of long-term administration of CF102 at 3 different dose levels in patients with HCC, and to determine the pharmacokinetic behavior of CF102 in this patient population. The secondary objective of the trial was to document evidence of clinical efficacy and to look at the correlation between A3 adenosine receptor expression levels at base line and patients' response to CF102.

The study data demonstrate that the trial objectives were successfully achieved, showing a very favorable safety profile for CF102 in a patient population with hepatocellular carcinoma and Child-Pugh cirrhosis classes A and B. In addition, the median overall survival time was 7.8 months, which is very encouraging data given that most patients were treated in the second-line setting and some were Child-Pugh class B. Remarkably, the median overall survival time of the Child-Pugh B patients was 9.4 months, the longest overall survival time that has been reported in the literature for this patient population.

Out of the 18 patients, 9 were infected with Hepatitis C. In 7 patients treated with the high CF102 dosages, a reduction in HCV load was observed.

According to Dr. Keith Stuart, MD, Chairman, Department of Hematology and Oncology, Lahey Clinic Medical Center, Professor of Medicine, Tufts University School of Medicine: "The safety and efficacy data of the CF102 Liver Cancer study are impressive and encouraging in the context of other investigational drugs. Therefore, I would recommend further clinical development of this drug for the treatment of patients with hepatocellular carcinoma. I hope that the present data will be reproducible and that patients could benefit from this drug."

In parallel, the company also announced today that a separate phase 1/2 study in patients with Hepatitis C (HCV) reached the study's primary objectives of safety and pharmacokinetic behavior. However, a reduction in the HCV viral load was not observed. It should be noted that patients on this study were treated for several months only with the low dose of CF102.

According to Dr. Pnina Fishman, the company CEO, "We are very pleased that the study achieved all of its objectives in patients with HCC, most of whom had failed prior treatment with Nexavar. The impressive results in the HCC study encourage us to continue development of CF102 in patients with Liver Cancer. We will focus on this disease and will continue to observe the viral load of HCC patients who also suffer from HCV.