Can-Fite Begins Dosing in Phase IIa Pancreatic Cancer Trial

Can-Fite BioPharma Ltd., a biotechnology firm known for its development of small molecule drugs targeting cancer and inflammatory diseases, has commenced dosing in a Phase IIa clinical trial for patients with advanced pancreatic adenocarcinoma. This marks a significant step for the company's drug candidate Namodenoson, which is being explored for its potential to address treatment gaps in pancreatic cancer.

Dr. Michael Silverman, Can-Fite’s Medical Officer, expressed enthusiasm about the trial, highlighting the potential to demonstrate Namodenoson’s safety and efficacy in a patient population with limited effective treatment options. The study aims to investigate the drug's safety profile and clinical activity in individuals whose disease has progressed despite first-line treatments.

The Phase IIa trial is an open-label, multicenter study involving 20 evaluable patients with advanced pancreatic adenocarcinoma. Participants are administered 25 mg of Namodenoson orally, twice daily, over consecutive 28-day cycles. Regular safety evaluations are conducted throughout the study. The primary goal is to assess the safety of Namodenoson, while secondary objectives include measuring clinical activity through various parameters such as the Objective Response Rate (ORR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

The trial is being led by Dr. Salomon Stemmer at the Institute of Oncology, Rabin Medical Center in Israel, and Dr. Al Mutar at the UT Southwestern Medical Center in the United States. Recently, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Namodenoson, recognizing its potential for treating rare diseases.

Namodenoson is a small, orally bioavailable drug that selectively binds to the A3 adenosine receptor (A3AR), which is highly expressed in diseased cells but not in normal cells. This selective targeting is believed to contribute to Namodenoson’s favorable safety profile. Previous Phase II trials have evaluated Namodenoson for other indications, such as hepatocellular carcinoma and non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Can-Fite BioPharma Ltd. is an advanced clinical-stage drug development company that focuses on creating treatments for cancer, liver, and inflammatory diseases. The company’s leading drug candidate, Piclidenoson, has recently completed a Phase III trial for psoriasis. Namodenoson, another key drug in their portfolio, is undergoing Phase IIb trials for NAFLD and NASH and a Phase III trial for hepatocellular carcinoma (HCC). The company is also planning further studies for pancreatic cancer.

Namodenoson has received Orphan Drug Designation in both the U.S. and Europe and Fast Track Designation from the U.S. FDA as a second-line treatment for HCC. Additionally, it has demonstrated potential efficacy in treating other cancers, including colon, prostate, and melanoma. Can-Fite’s third drug candidate, CF602, has shown promise in treating erectile dysfunction. Across its clinical studies, the company's drugs have shown excellent safety profiles with extensive testing in over 1,600 patients.

Can-Fite is committed to advancing its pipeline of proprietary drugs, addressing significant gaps in current treatment options for serious diseases. With a focus on innovation and patient safety, the company continues to pursue its mission of developing effective therapies for unmet medical needs.