【Can-Fite BioPharma- Product CF101&CF102】Can-Fite Initiates Preclinical Studies Required by FDA and EMA for the Registration of its Two Lead Drug Candidates

Partner News

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

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

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.

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.

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