07 August 2019 | News
Namodenoson has both Fast Track and Orphan Drug Status with USFDA
Can-Fite BioPharma Ltd, a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced that a supply of Namodenoson has been manufactured and is ready for use in the treatment of advanced liver cancer patients under compassionate use at the Rabin Medical Center in Israel.
Compassionate use allows doctors and their patients the option of early access to investigational new drugs, under closely controlled and monitored circumstances, when a patient who is facing serious illness has exhausted all available treatment options.
Salomon M. Stemmer, MD, the Principal Investigator of the Company’s prior Phase II liver cancer study said, “Given the evidence of clinical benefit of Namodenoson in patients with hepatocellular carcinoma and Child Pugh B7 to whom there is no accepted well established treatment, I plan to offer Namodenoson to certain HCC CPB7 patients in the compassionate use setting.”
Can-Fite recently announced results from its Phase II study of Namodenoson in the treatment of advanced liver cancer. Namodenoson was found to increase overall survival in HCC patients with Child Pugh B7, the largest subpopulation of the study, as compared to placebo, even though the trial did not meet its primary endpoint.
An end of Phase II meeting with the U.S. Food and Drug Administration to review study data and to present the design of a Phase III clinical trial is expected soon.
The FDA has granted Namodenoson both Orphan Drug and Fast Track status providing a pathway for accelerated approval based on unmet need in the treatment of advanced liver cancer.