9th July, 2021—Can-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.
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.
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.