Drug developer Can-Fite BioPharma Ltd. (TASE:CFBI) today announced that it has begun recruiting patents for the Phase II/III clinical trial of its CF101 drug for the treatment of psoriasis. 300 patients will be included in the six-month trial at medical centers in Israel, Europe, and the US.
Can-Fite will publish interim results when treatment of the first 100 patients is completed. The trial's primary endpoint is improvement in the physician global assessment (PGA) values, which the US Food and Drug Administration (FDA) has approved as the measure for registering psoriasis treatments. Can-Fite reported statistically significant improvement in the PGA values in the Phase II trial of CF101, which used a similar protocol as the current trial.
On the basis of the positive results in the Phase II trial, and CF101's maximum safety profile for the treatment of psoriasis, the FDA approved Can-Fite's Investigational New Drug (IND) application for the Phase II/III trial.
Can-Fite CEO Prof. Pnina Fishman said, "We are very pleased with the completion of the regulatory procedures in the countries where the trial will be held and by the start of patient recruitment for this trial for the treatment of psoriasis under an FDA IND application. This trial is another important step in the development of CF101, and we hope that this drug will help cure patients with psoriasis, who currently have no comparable effective drug with an excellent safety profile and no major side effects."
Can-Fite's share price rose 1.3% by mid-afternoon to NIS 0.68, giving a market cap of NIS 156 million.
Published by Globes [online], Israel business news - www.globes-online.com - on August 1, 2011
© Copyright of Globes Publisher Itonut (1983) Ltd. 2011