Ramat Gan, Israel, July 1, 2026
Can-Fite BioPharma Ltd. announced that its Phase 2a clinical study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma (PDAC) successfully achieved its primary safety endpoint while demonstrating encouraging durable overall survival outcomes in heavily pretreated patients. The open-label study enrolled 20 patients with advanced pancreatic cancer who had progressed following standard therapies, including 14 third-line, five second-line, and one fourth-line patient. Namodenoson was well tolerated, with a safety profile consistent with previous clinical studies, reinforcing its favorable risk-benefit profile. The updated survival analysis identified a subgroup of patients who achieved prolonged survival despite advanced disease, supporting further clinical development of the oral A3 adenosine receptor (A3AR) agonist. Based on these findings and supporting preclinical evidence, Can-Fite plans to advance Namodenoson into a Phase 2b combination study with chemotherapy.
Phase 2a Study Demonstrates Durable Survival in Heavily Pretreated Patients
The Phase 2a trial focused on patients with advanced pancreatic ductal adenocarcinoma, one of the most aggressive and treatment-resistant cancers. Following extended follow-up, investigators analyzed outcomes among eight evaluable third-line patients who survived at least two months after treatment initiation, excluding individuals with rapidly progressing disease unlikely to benefit from systemic therapy. Results showed a median overall survival exceeding five months, with 62.5% of patients surviving five months or longer and 37.5% surviving beyond seven months. Two patients remained alive at the data cutoff, including one patient continuing active treatment and another being followed for nearly nine months. Investigators also observed durable disease control, with progression-free survival extending beyond seven months in selected patients. Among the five second-line patients, one individual remained alive more than 18 months after initiating Namodenoson therapy, representing the longest survival recorded in the study and highlighting the drug’s potential benefit in earlier treatment settings.
Safety Profile and Mechanism Support Combination Therapy Development
Namodenoson continued to demonstrate an excellent safety profile, consistent with previous clinical experience across multiple therapeutic indications. The therapy selectively targets the A3 adenosine receptor (A3AR), which is highly expressed in diseased and cancerous cells while remaining minimally expressed in normal tissues, contributing to its targeted activity and favorable tolerability. According to Professor Salomon Stemmer, principal investigator of the study and oncology expert at the Davidoff Institute of Oncology, Rabin Medical Center, the combination of prolonged survival and favorable safety supports continued clinical investigation. Recently published peer-reviewed preclinical research further strengthened the rationale for combination therapy by demonstrating that Namodenoson enhances the anti-tumor effects of chemotherapy through simultaneous inhibition of multiple cancer growth and drug-resistance pathways, including Wnt/β-catenin and Hedgehog signaling, while reducing multidrug-resistance protein expression and increasing chemotherapy sensitivity in pancreatic cancer models.
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Phase 2b Combination Trial Planned as Clinical Development Expands
Encouraged by the Phase 2a findings, Can-Fite BioPharma plans to initiate a Phase 2b clinical trial evaluating Namodenoson in combination with chemotherapy for advanced pancreatic cancer. The upcoming study aims to build upon both the encouraging clinical survival signals and the growing body of mechanistic evidence supporting synergistic anti-tumor activity. Beyond pancreatic cancer, Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced hepatocellular carcinoma (HCC) and an ongoing Phase 2b trial for metabolic dysfunction-associated steatohepatitis (MASH). The drug has received Orphan Drug Designation in both the United States and Europe and FDA Fast Track Designation for second-line HCC treatment. With clinical experience in more than 1,600 patients, Can-Fite continues to advance Namodenoson as a promising targeted therapy across multiple oncology and liver disease indications, while the latest pancreatic cancer data provide additional momentum toward expanding its clinical development strategy.
Source: Can-Fite BioPharma press release
