Namodenoson induced a complete response with disappearance of all metastases in a patient who will now continue the treatment under a compassionate use program in Romania
Can Fite’s Phase III pivotal study is open for patient enrolment
23th August, 2022- Can-Fite BioPharma issued a press release, which is summarized as follows:
Can Fite’s liver drug candidate Namodenoson has been approved for compassionate use for the treatment of patients with advanced liver cancer in Romania. Namodenoson was previously approved for compassionate use in Israel, where advanced liver cancer patients have been treated for several years.
In parallel, Can-Fite’s pivotal Phase III study in patients with advanced liver cancer (hepatocellular carcinoma), is open for patient enrolment and will recruit patients in Israel, the U.S., and five countries in Europe. This pivotal study received a ‘green light’ to proceed from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and if successfully concluded, the Company will be in a position to submit the drug for approval with each of the regulatory authorities. Namodenoson has Orphan Drug Status with both the FDA and EMA and Fast Track Status with the FDA. A registration plan has been submitted to and accepted by the FDA.
The original website link: https://ir.canfite.com/news-events/press-releases/detail/997/can-fites-drug-namodenoson-approved-for-compassionate