Following FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite's Namodenoson, Leading U.S. Medical Centers Seek Authorization for their Patients
Ramat Gan, Israel, April 17, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that leading Medical Centers in the US are approaching the FDA, asking for compassionate use approval to treat patients with pancreatic carcinoma with the company oncological drug Namodenoson.
Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols.
Simultaneously, Can-Fite is actively enrolling patients in Israel for a Phase IIa study—an open-label trial designed for individuals with advanced pancreatic adenocarcinoma whose disease has progressed despite at least first-line therapy. The trial aims to assess the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this challenging patient population. The study is led by Dr. Salomon Stemmer, a renowned key opinion leader at the Institute of Oncology, Rabin Medical Center, Israel. Notably, Namodenoson has been granted Orphan Drug Designation by the U.S. FDA, further underscoring its potential as a promising therapeutic option.
"We are thrilled that more top-tier U.S. medical centers are recognizing the potential of Namodenoson and are eager to participate in our compassionate use program," said Motti Farbstein, CEO of Can-Fite. "Our goal is to provide this underserved patient population with a novel treatment that may extend survival and improve quality of life."
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion-dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: https://www.canfite.com/.
Forward-Looking Statements
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Contact
Can-Fite BioPharma
Motti Farbstein
+972-3-9241114
