Ramat Gan, Israel — Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced positive clinical data from its Phase 2a study of namodenoson in patients with advanced pancreatic cancer.
The data from the fully enrolled study demonstrate preliminary evidence of clinical activity, including durable disease stabilization in a heavily pretreated patient population, in addition to the previously reported favorable safety profile.
Key findings include:
· Stable disease observed in >30% of evaluable patients
· Prolonged treatment duration includes one patient extending beyond 16 months.
· 35% of patients remain on therapy and follow up
· Favorable safety and tolerability profile consistent with prior reports
The prolonged treatment duration observed in several patients suggests a potential for durable clinical benefit in this difficult-to-treat population.
“As we continue to analyse the data, we are encouraged by the emerging signal of durable disease stabilization observed in this study,” said Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite. “Importantly, a meaningful proportion of patients remain on therapy for extended periods, supporting the continued clinical development of namodenoson in pancreatic cancer.”
As a substantial proportion of patients remain on treatment, full efficacy analyses, including progression-free survival and overall survival, top-line results are expected in the coming months and will be presented in a forthcoming clinical conference.
About Namodenoson
Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.
Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
About Pancreatic Cancer Phase 2a Study
The Phase 2a study of namodenoson is an open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of namodenoson in this population. All patients receive oral namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients are being evaluated regularly for safety. 20 evaluable patients were enrolled to the study. The primary objective of this trial is to characterize the safety profile of namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). The study met its primary endpoint, which was safety, demonstrating that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: 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 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a 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/.
Contact
Can-Fite BioPharma
Motti Farbstein
+972-3-9241114