Can-Fite BioPharma provides update on Namodenoson to treat liver cancer

Can-Fite BioPharma provided an update on its clinical program for Namodenoson in the treatment of hepatocellular carcinoma, HCC, the most common form of liver cancer. A pivotal Phase III registration study is open for enrollment of the most advanced liver cancer patients. At two upcoming bio-partnering conferences, Can-Fite will be presenting the latest data comparing the response of liver cancer patients to those with HCC Child-Pugh B or CPB , the most advanced liver cancer. The Company will also share the latest findings on a CPB liver cancer patient who remains cancer-free 6 years after she began treatment with Namodenoson…Can-Fite has received agreement from both the U.S. Food and Drug Administration FDA and European Medicines Agency EMA on its Phase III pivotal liver cancer study which is now open for enrollment. 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. The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying 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. An interim analysis will be conducted by an Independent Data Monitoring Committee 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.