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Can-Fite BioPharma Ltd (NYSE:CANF) announced that a patient who participated in the Phase 2 Liver Cancer Study and was treated with namodenoson had a complete response and overall survival of 6.9 years (82.8 months).
A patient with advanced hepatocellular carcinoma (HCC) who was enrolled in the former Can-Fite Phase 2 study continues to receive treatment with namodenoson and has now an overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life and defined as a complete response.
Can-Fite has received agreement from both the FDA and the European Medicines Agency on a pivotal Phase 3 clinical study, which is now enrolling patients.
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 a matching placebo twice daily.
The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes will be assessed, such as tumor radiographic response rates, median progression-free survival, and standard safety parameters.
An Independent Data Monitoring Committee will conduct an interim analysis after treating 50% of enrolled patients. 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.
Price Action: CANF shares are up 17.7% at $2.36 on the last check Tuesday.
Posted In: CANF
