Ramat Gan, Israel — Can-Fite BioPharma Ltd. (NYSE American: CANF; TASE: CANF), a clinical-stage biotechnology company developing oral small molecule drugs targeting the A3 adenosine receptor (A3AR), today announced plans to advance its pancreatic cancer program into a Phase 2b study evaluating Namodenoson in combination with immunotherapy in patients with advanced pancreatic cancer.
The planned Phase 2b study follows encouraging findings from the Company’s ongoing Phase 2a study evaluating Namodenoson in patients with advanced pancreatic adenocarcinoma who progressed following at least one prior line of therapy. The Phase 2a study demonstrated a favorable safety profile together with clinical activity manifested by prolonged treatment duration in a subset of patients including treatment extending beyond 16 months, stable disease observed in >30% of evaluable patients and 35% of patients remain on therapy and follow up.
The upcoming Phase 2b study is expected to evaluate Namodenoson in combination with immunotherapy in order to further assess clinical benefit, including progression-free survival, overall survival, disease stabilization, and additional efficacy endpoints.
“We are encouraged by the emerging data from our ongoing pancreatic cancer study and believe the advancement into a combination Phase 2b trial represents an important next step in the development of Namodenoson for this devastating disease,” said Dr. Salomon Stemmer, who is leading the Phase 2a study and is an oncology key opinion leader and Professor at the Davidoff Institute of Oncology, Rabin Medical Center, Israel. “Pancreatic cancer remains one of the deadliest malignancies with very limited therapeutic options, particularly in advanced disease. We believe Namodenoson’s favorable safety profile together with its potential additive effect with chemotherapy support continued clinical advancement of the program.”
The Company further announced that details of the planned Phase 2b study design are expected to be discussed during the upcoming BIO International Convention in San Diego, where Dr. Sari Fishman, VP Business Development of Can-Fite, is scheduled to meet with leading oncology companies. Can-Fite has already entered into confidentiality agreements with several pharmaceutical companies that are evaluating potential partnership opportunities related to the pancreatic cancer program.
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 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: www.canfite.com.
Contact
Can-Fite BioPharma
Motti Farbstein
[email protected]
+972-3-9241114