Can-Fite BioPharma Ltd. (CANF), Thursday announced that the U.S. Food and Drug Administration has granted compassionate use approval for Namodenoson, its oral small molecule drug targeting the A3 adenosine receptor or A3AR, to treat a patient with advanced pancreatic carcinoma.
The company said this marks the first-ever FDA compassionate use approval for Namodenoson in pancreatic cancer and reflects growing interest in the drug's potential from leading U.S. medical centers, which are now actively seeking similar authorizations for their own patients under compassionate use protocols.
The approval follows the drug's Orphan Drug Designation by the FDA for pancreatic cancer and coincides with Can-Fite's ongoing Phase IIa clinical trial in Israel for patients with advanced pancreatic adenocarcinoma who have failed at least first-line therapy.
"Receiving compassionate use approval in the U.S. represents a significant milestone in Namodenoson's development and highlights the urgent need for new therapies in pancreatic cancer," said Motti Farbstein, Chief Executive Officer of Can-Fite BioPharma.
"Our goal is to provide patients with a safe and effective treatment option that may improve both survival and quality of life."
Namodenoson is also in Phase III development for hepatocellular carcinoma or HCC and Phase IIb for Metabolic Dysfunction-associated Steatohepatitis or MASH.
It has demonstrated a strong safety profile in over 1,600 patients and targets the A3AR, which is highly expressed in tumor and inflammatory cells but minimally in healthy tissue.
Can-Fite expects continued expansion of its compassionate use program in the U.S. as more oncology centers pursue treatment access for patients with few remaining options.
Currently, CANF is trading at $1.20 down 1.6 percent on the New York Stock Exchange.
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