Full Press Release Details
to Initiate Exploratory Phase 2 Trial with Namodenoson in Pancreatic Cancer Patients
TIKVA, Israel, May 9, 2023 -- Can-Fite BioPharma Ltd.
(NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory,
cancer and liver diseases, today announced that it will initiate an open-label Phase 2 exploratory trial to assess the efficacy and safety
of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy.
will receive Namodenoson at a dose of 25 mg orally, twice daily. Efficacy endpoints will include objective response, progression-free
survival, duration of response, disease control (defined as an objective response or stable disease), and overall survival. Safety will
be assessed as well. The study will be conducted by Dr. Salomon Stemmer, an oncology key opinion leader and Professor at the Institute
of Oncology, Rabin Medical Center, Israel.
is currently under a pivotal Phase 3 study for the treatment of advanced liver cancer and has completely cleared cancer in an advanced
liver cancer patient who remains cancer-free 6 years after starting treatment.
relatively small exploratory trial is designed as an open-label study, enabling us to assess the potential efficacy of Namodenoson in
pancreatic cancer. We've seen Namodenoson's potent anti-cancer effects in treating people with liver cancer and believe that
based on recent pre-clinical results, our drug may be equally effective in pancreatic cancer, an indication in need of more effective
treatments," stated Can-Fite CEO Dr. Pnina Fishman.
highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology
(ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease.
The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen
Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion
in 2021 and is projected to grow to approximately $6.6 billion by 2030.
is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was
evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic
fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression
is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
Can-Fite BioPharma Ltd.
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 III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is
being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence
in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.
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