Can-Fite BioPharma completes patient enrollment for Phase II Namodenoson study
Can-Fite BioPharma announced that the Phase II liver cancer clinical trial for Namodenoson, a novel compound for the treatment of advanced hepatocellular carcinoma, has successfully enrolled and randomized all 78 patients planned in the clinical trial protocol. The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, are treated twice daily with 25 mg of oral Namodenoson, the dose found to be the most efficacious in Can-Fite's earlier Phase I/II study. The primary endpoint of the Phase II study is Overall Survival. Secondary endpoints include Progression Free Survival, safety, and the relationship between outcomes and A3AR expression. As is standard in this indication, the primary endpoint of OS requires following the entire patient population until the statistically predetermined number of events occur. Can-Fite is following the survival data closely and will perform the survival analysis at the earliest possible opportunity. Can-Fite's prior Phase I/II study of Namodenoson in this indication successfully achieved its primary and secondary endpoints, with a good safety profile. Most of the patients enrolled in the Phase I/II study had failed prior treatment with Nexavar, the only drug currently approved for this indication. Data also showed that Namodenoson has a liver protective effect that is very unique compared to Nexavar and other drugs under development for HCC which have shown to induce hepato-toxicity.