29th Nov，2019 — Can-Fite BioPharma Ltd. issued an announcement, which is summarized as follows:
Reached Agreement with U.S. FDA on Phase III Study Design for Namodenoson in Liver Cancer – Can-Fite concluded a successful End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA) regarding its recently completed Phase II study of Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer. The FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application submission and approval. The Phase III study design is now being finalized based on guidance from the FDA, and Can-Fite expects to initiate the study in the second half of 2020.
Treating Liver Cancer Patients Under Compassionate Use – Can-Fite enrolled and started treating HCC patients with Namodenoson under its compassionate use program at the Rabin Medical Center in Israel. The approved compassionate use program gives HCC patients early access to treatment with Namodenoson when patients have exhausted other available treatment options.
Completed Patient Enrollment in Phase II NASH Study – Can-Fite completed enrollment of 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH (non-alcoholic steatohepatitis). The Company plans to announce topline results in the first quarter of 2020.
Signed Distribution Deal for Piclidenoson in South Korea & Received Upfront Payment – Can-Fite entered into an exclusive distribution agreement with Kyongbo Pharm for Piclidenoson in the treatment of psoriasis in South Korea. Can-Fite received an upfront payment of $750,000, and the agreement includes milestone payments of up to $3,250,000 plus transfer pricing on the drug, upon regulatory approval in South Korea.
Enrolling Patients in Phase III Studies for Piclidenoson in Rheumatoid Arthritis and Psoriasis — Can-Fite and Gebro Pharma conducted an International Advisory Board conference for the development and commercialization of Piclidenoson with a panel of Key Opinion Leaders in rheumatoid arthritis from Austria, Switzerland, and Spain, the markets for which Gebro has licensed the distribution rights to Piclidenoson for rheumatoid arthritis and psoriasis. Can-Fite is currently enrolling and treating patients in Phase III global studies for these two indications.
Entered Collaboration Agreement to Develop Cannabinoid-Based Pharmaceuticals and Assays – Can-Fite signed an agreement with Univo Pharmaceuticals (TASE:UNVO), a medical cannabis company, to identify and co-develop specific formulations of cannabis components for the treatment of cancer, inflammatory, autoimmune, and metabolic diseases. Can-Fite will contribute its unparalleled expertise in A2AR, which binds with cannabinoids, and is the target of Can-Fite’s technology platform. The transaction involves technology exchange, co-development, and revenue share on CBD-based pharmaceuticals and CBD-based A3AR assays.
Granted Patents for Sexual Dysfunction Drug, Evaluating Strategic Partnerships – Can-Fite increased its patent portfolio for its drug candidate CF602 in the treatment of sexual dysfunction. Patents were recently granted in Canada, South Korea, and Israel for its patent titled, “A3 adenosine receptor ligands for use in treatment of a sexual dysfunction”. CF602 has a unique mechanism of action that makes it suitable to potentially treat sexual dysfunction safely in patients with diabetes mellitus, a clear and unmet need in the market today. Can-Fite is actively looking for and evaluating potential strategic partners that may in-license and develop CF602 in this indication.
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