27th May, 2021—Can-Fite
BioPharma Ltd. today announced financial results for the quarter ended March
Phase III Psoriasis Study Achieves 75%
Enrollment – The Phase III Comfort? study completed enrollment of 75% of
planned patients for the study which is designed to establish Piclidenoson’s
superiority compared to placebo and non-inferiority compared to Apremilast
(Otezla®) in patients with moderate to severe plaque psoriasis. The majority of
costs associated with the Phase III Comfort? study have been previously paid.
The Company expects to complete enrollment in Q3 2021 and report topline
results in Q4 2021.
Phase II COVID-19 Study Expands to Europe
– Can-Fite is enrolling 40 patients hospitalized with moderate to severe
COVID-19 in its Phase II study, under a U.S. Food and Drug Administration (FDA)
approved protocol, in Israel and Europe.
Phase IIb NASH Study Expected to Commence
Q4 2021 – Based on a successfully concluded Phase IIa NASH/NAFLD study with
Namodenoson which met its primary endpoint, Can-Fite completed the design of a
Phase IIb study with the help of top NASH Key Opinion Leaders, Dr. Friedman and
Dr. Harrison, and the Company plans to commence the Phase IIb study before the
end of 2021.
Pivotal Phase III Liver Cancer Study
Expected to Commence Q4 2021 – Can-Fite is preparing to commence its pivotal
Phase III trial for the treatment of hepatocellular carcinoma (HCC) based on a
protocol agreed upon with the U.S. FDA and the European Medicines Agency.
Should the study meet its efficacy endpoint and be approved by the FDA and EMA,
Namodenoson would become one of only a few drugs available to treat advanced
liver cancer patients. Recently announced data from Can-Fite’s Phase II
advanced liver cancer study included overall survival of 4 years in two
patients. Additional findings show disappearance of ascites, normal liver
function and good quality of life. A scientific paper titled, “Namodenoson in
Advanced Hepatocellular Carcinoma and Child–Pugh B Cirrhosis: Randomized
Placebo-Controlled Clinical Trial” published in the peer reviewed journal
Cancers provided more in-depth data from the Phase II study including a
significant 12-month overall survival benefit in the CPB7 population, the
target population for the pivotal Phase III study.