¡¾Can-Fite BioPharma-Product CF102¡¿Can-Fite Gears Up to Initiate Pivotal Phase III Liver Cancer Study
2021-07-12 10:23

9th July, 2021¡ªCan-Fite BioPharma Ltd. today announced it has completed preparatory work ahead of the anticipated initiation of patient enrollment for its pivotal Phase III registration trial of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.

Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on the protocol and plans to submit it for Institutional Review Board (IRB) approvals in the coming weeks. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel.

The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed.

The Company plans to conduct an interim analysis by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been or are no longer effective.

¡°We are eager to commence this study, as there is a dire need for a safe and effective treatment for patients with advanced liver disease, defined as CPB7, where Namodenoson has an advantage with its liver protective effect,¡± stated Can-Fite CEO Dr. Pnina Fishman.

The original website link:

https://ir.canfite.com/news-events/press-releases/detail/957/can-fite-gears-up-to-initiate-pivotal-phase-iii-liver