20th December, 2021 – Can-Fite BioPharma issued a press release, which is
summarized as follows:
Can-Fite BioPharma
announced that the last patient treated under an Open
Label Extension program of its concluded Phase II study of Namodenoson in the
treatment of hepatocellular carcinoma (HCC) experienced a Complete Response
(CR) to Can-Fite’s drug, meaning that all cancer lesions have cleared.
Under treatment with Namodenoson, the patient has now survived five years,
during which time the clinical benefits of treatment have included the
disappearance of ascites, normal liver function, and the disappearance of peritoneal
carcinomatosis leading to complete clearance of all cancer lesions.
“Complete Response of HCC in an advanced stage is a
rare but highly beneficial result in the field of liver cancer treatment. It is
our hope that our upcoming pivotal Phase III study will demonstrate
Namodenoson’s efficacy in treating patients with similarly advanced HCC and
thereby potentially offer longer survival to liver cancer patients across the
world,” stated Can-Fite’s Medical Director Dr. Michael Silverman.
In the first quarter of 2022, Can-Fite expects to
commence patient enrollment in its pivotal Phase III trial for Namodenoson in
the treatment of patients with advanced HCC with underlying Child Pugh B7
(CPB7) cirrhosis to support a New Drug Application (NDA) submission and
approval. Both the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) have agreed with the
design of the 471-patient study.
Namodenoson has Orphan Drug Designation for HCC in the U.S. and Europe,
has Fast Track Status in the U.S., and is currently treating liver cancer
patients through a compassionate use program in Israel.
The original website link: https://ir.canfite.com/news-events/press-releases/detail/975/liver-cancer-patient-treated-with-can-fites-namodenoson