¡¾Can-Fite BioPharma- Product CF101&CF102¡¿Can-Fite Initiates Preclinical Studies Required by FDA and EMA for the Registration of its Two Lead Drug Candidates
2021-04-20 19:39

20th April, 2021-- Can-Fite BioPharma Ltd. today issued a new, which is summarized as follows:

Can-Fite 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.

The original website link:

https://ir.canfite.com/news-events/press-releases/detail/947/can-fite-initiates-preclinical-studies-required-by-fda-and