Can-Fite BioPharma Ltd. (TASE:CFBI) reported a significant
Analysis by the company of the connection between the target receptor (A3), which CF102 attacks, and the patients’ reaction to the drug found that in 85% of the cases, there was an overreaction by the receptor and corresponding improvement in the patients taking the drug. This finding indicates that the A3 receptor can serve as a biomarker to predict the patients’ reaction to treatment with CF102.
The new finding follows the announcement earlier this month that the safety and efficacy trial had achieved its primary and secondary endpoints.
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.