Can Fite BioPharma Ltd (CANF)

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Can-Fite Initiates Preclinical Studies Required by FDA and EMA for the Registration of its Two Lead Drug Candidates


https://finance.yahoo.com/news/fite-initiates-preclinical-studies-required-110000838.html

Tue, April 20, 2021, 2:00 PM

Piclidenoson in Phase III for Psoriasis & Namodenoson to Enter Pivotal Phase III for Liver Cancer

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory and liver diseases, announced today that in preparation for anticipated potential marketing registration filings for its drug candidates Piclidenoson and Namodenoson in the U.S. and Europe, the Company has initiated a series of preclinical studies required by regulators.

As part of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), both regulators require certain preclinical data be submitted along with the pivotal Phase III data.

Piclidenoson is now being evaluated in the COMFORT Phase III clinical study which continues to enroll patients following a positive interim data analysis. The COMFORT study is designed to establish Piclidenoson’s superiority as compared to placebo and non-inferiority compared to Otezla® in patients with moderate-to-severe plaque psoriasis.

A pivotal Phase III study of Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer, is expected to commence in the fourth quarter of 2021. Namodenoson has Orphan Drug Status in the U.S. and Europe and Fast Track Status with the FDA. Can-Fite has reached agreement with both the FDA and EMA on the study design and upon successful results, the trial may lead to concurrent marketing approval in the U.S. and Europe.

"Having commenced these important preclinical studies for our lead indications in anticipation of potential NDA and MAA filings, we are eager to bring our drug candidates to market for the benefit of patients in need," stated Can-Fite CEO Dr. Pnina Fishman.