3th June 2019 – Can-Fite BioPharma Limited issued an announcement, which is summarized as follows:
*Phase III study protocol for Namodenoson in the treatment of advanced liver cancer patients is now being prepared and will be presented to FDA in an End of Phase II meeting
Can-Fite BioPharma Ltd. announced that data from its recently completed Phase II trial in patients with hepatocellular cancer (HCC), the most common form of liver cancer, was presented at the late-breaking abstract session of the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO), the world’s largest clinical cancer research meeting.
Prof. Salomon M. Stemmer, Principal Investigator of Can-Fite’s Phase II trial, delivered the presentation. The presentation is entitled: “A phase II, randomized, double-blind, placebo-controlled trial evaluating efficacy and safety of Namodenoson (CF102), an a3 adenosine receptor agonist (A3AR), as a second-line treatment in patients with Child-Pugh B advanced HCC.” While the Phase II study did not achieve its primary endpoint of overall survival in the whole population (n=78), superiority in overall survival was found in the largest study subpopulation of patients who were classified Child Pugh B7 (n=56) based on severity of disease compared to the placebo treated group. Median survival in the Namodenoson group (n = 34) was 6.8 months, versus 4.3 months for the placebo group (n = 18) (Hazard Ratio = 0.77, p = 0.40).
The most impressive finding was that 44% of the patients with Child Pugh B7 treated with Namodenoson were alive at one year compared to 18% in the placebo group. In the overall patient population, among patients who had at least one assessment post baseline, disease control was significant in the Namodenoson group, 26% versus 10% in the control group after four months of treatment, P value 0.013. Among the other positive findings that were presented is the 9% partial response in the Namodenoson treated group vs. 0% in the placebo group.
A3AR expression level at baseline was 1.98±0.36 in comparison to 1 unit in healthy subjects and was not changed substantially during the treatment period, demonstrating that continuous treatment with Namodenoson does not result in de-sensitization or loss of the target. Consistent with its previously demonstrated favorable safety profile, Namodenoson showed an adverse event profile that was comparable to that of placebo.
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