Drug development company Can-Fite BioPharma Ltd. (TASE:CFBI) today announced success in a large Phase II clinical trial of its drug, CF101, to treat patients with moderate to severe Psoriasis.
Psoriasis is a skin condition that affects 2-3% of the general population. The market for psoriasis drugs is estimated at $3.5 billion annually. General anti-inflammatory agents are only partially effective and are limited by safety problems. New biologics targeting the underlying immune pathogenesis of the disease have been introduced, which while effective, are expensive and cause side effects characteristic of these types of medications.
CF101 has already been tested on more than 650 patients in past studies, and shown to be both safe and effective.
The Phase II trial included 75 patients, who were randomly assigned either various dosages of CF101 or a placebo. The drug was administered as a stand-alone treatment over 12 weeks. It was conducted under US Food and Drug Administration (FDA) guidelines at medical centers in Israel and Europe. The trial results were statistically significant, and progressive over time, suggesting that longer treatment will result in further improvement, particularly for patients who received 2 mg dosages.
Can-Fite believes that the fact that the 2 mg dosage of CF101 was shown to be the most effective dose has far-reaching consequences for further development of the drug, and could shorten the development timetable.
The company says that it has several alternatives for further development of the drug, including a Phase IIb or a Phase III clinical trial. It will review the results of the present trial, and after studying them and consulting with the FDA, it will decide on the nature of the next trial and drug development stages.
Can-Fite has already reported successful trial results for CF101 as a stand-alone treatment for dry-eye disease, which is also an inflammatory disease. Successes in trials for both diseases suggest that CF101 has general applications for inflammatory diseases, and that the drug's potential markets could be worth billions of dollars altogether.
The trial's principal investigator, Dr. Michael David, Head of the Department of Dermatology at the Rabin Medical Center, said, “The study data is impressive and promising. CF101 is a unique small molecule orally bio-available drug with an impressive safety profile based on accumulated experience in more than 700 patients. There is a market need in psoriasis for small molecule drugs and I am confident that Can-Fite should progress with the clinical development of CF101 based on the study data."
Can-Fite CEO Pnina Fishman added, "We're very pleased by the trial results, which further confirms the effectiveness of CF101 for treating inflammatory diseases. The success of this trial, as well as the success in the previous trial, gives solid grounds for hoping that the drug will be a commercial success, as well as validating the technology platform that underpins Can-Fite's development. We hope that we can bring relief of sufferers of psoriasis, who currently have no similar treatment that is both effective and without side effects."
Can-Fite's share rose 5% in morning trading to NIS 0.93, giving a market cap of NIS 190 million.
Published by Globes [online], Israel business news - www.globes-online.com - on September 7, 2009
© Copyright of Globes Publisher Itonut (1983) Ltd. 2009