Can-Fite BioPharma Ltd. (TASE:CFBI) has obtained US Food and Drug Administration (FDA) approval for a phase II/III clinical trial of CF101 for the treatment of the skin disease psoriasis. The trial follows the successful results of the phase II and safety and effectiveness trials and meetings between company officials and the FDA on the Investigational New Drug (IND) Application.
FDA officials were satisfied with the preclinical and clinical trials of CF101 for the treatment of psoriasis, as well as from the results of the safety trial and detailed report that Can-Fite submitted.
The new trial, which will begin in a few months, will include 300 patients in Israel, Europe, and the US.
Can-Fite says that psoriasis affects 2-3% of the population, and estimates the global market for treatment at $3.5 billion a year. Most current treatments are expensive biological drugs, which also have the characteristic side effects of these drugs.
CF101 is an anti-inflammatory drug, which the company is developing to treat psoriasis, dry eye syndrome and rheumatoid arthritis.
Can-Fite's share price rose 3.3% at the opening today to NIS 0.63, giving a market cap of NIS 132 million.
Published by Globes [online], Israel business news - www.globes-online.com - on June 6, 2010
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