Can-Fite BioPharma has secured approval from the FDA and EMA for a pivotal Phase 3 clinical trial for the treatment of advanced liver cancer. The trial is now underway in Israel, Europe, and the US and aims to enroll patients who have not responded to other approved therapies.

The drug being evaluated in the trial, namodenoson, has both Orphan Drug and Fast Track Status with the FDA for treating hepatocellular carcinoma (HCC). It is designed to bind to the A3 adenosine receptor (A3AR), which is highly expressed in diseased but not normal cells.

A conference was held to present the study protocol and procedures to oncologists and coordinators involved in the trial. Dr. Lencioni, a renowned radiologist, discussed the methodology for measuring tumor response to namodenoson. US experts guided the electronic data collection system used for patient data during the trial.

Namodenoson has shown promising results in previous Phase II trials as a second-line treatment for HCC, NAFLD, and NASH. Its favorable safety profile stems from its selective binding to A3AR, predominantly found in diseased cells.

The global incidence of liver cancer is significant, with HCC being a particularly aggressive form with low survival rates. As new and effective treatments emerge, the market for HCC therapies is projected to expand.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.