Can-Fite-Completed Patient Enrollment for the Phase II Trial in Psoriasis with CF101
News Jun 02, 2009
Can-Fite BioPharma has achieved yet another goal by completion of patients’ enrollment in its phase II Psoriasis trial. Approximately 70 patients were enrolled to this study, randomized into 4 groups treated with 1, 2 and 4 mg of CF101 and placebo.
Patients are taking the drug for 12 weeks plus 2 weeks of follow-up. The trial is being conducted in 10 sites in Israel and Europe. The company estimates to release study data on Q3 2009.
A point to note it that similarly to the patients in the Dry Eye study, which was recently successfully concluded, the patients in the current study were also treated with CF101 as a stand alone.
Psoriasis is a skin condition that affects 2% to 3% of the general population. The disease is manifested by scaly plaques on the skin and in the severe form has a major effect on the physical and emotional well-being of the patients. General anti-inflammatory agents such as topical corticosteroids, Methotrexate or phototherapy are only partially effective and are limited by safety issues.
Recently, novel biologics targeting the underlying immuno-pathogenesis of the disease have been introduced, such as Enbrel, which blocks the activity of the inflammatory cytokine tumor necrosis factor-a (TNF-a). Still, a significant need remains for novel drugs for patients who do not respond to existing therapies or for whom these therapies are unsuitable.
The market share for Psoriasis is estimated at US$ 3.5 billion annually. The oral administration of Can-Fite's CF101, the drug's mechanism of action (suppression of the inflammatory mediator TNF-a) and its safety profile (tested on more than 600 subjects in other trials), support its use for the treatment of psoriasis.
Prof. Pnina Fishman, CEO of Can-Fite, said today that, "We are very happy with the progress in our clinical development program and looking forward to analyze the data of this study in which CF101 was given as a monotherapy. It is our first trial in the dermatology field and the immuno-modulatory activities of CF101 render it a possible attractive drug candidate for these clinical conditions."