by Damian Stanclik
29. July 2010 09:38
The Can-Fite BioPharma has announced on the 8th of September 2010 that it has opened an Investigational New Drug application for a Phase 3 study, with its lead drug CF101 on patients with 'dry eye' syndrome.
'Dry eye' syndrome is known to greatly affect users of contact lenses. Based on recent data, it is believed to affect about 30 million people in US alone. Can-Fite entered the market for safe and effective treatment and since then they have been developing new ways for treating this disease – now entering Phase 3 with CF101 as a monotherapy.
During previous phases, CF101 was documented as having significant benefit in the removal of fluorescein staining in all parts of the cornea. It was also found to be safe and well tolerated by the patients. Can-Fite CEO Dr. Pnina Fishman said "We are now confident that the Phase 3 clinical protocol has the appropriate design features, clinical endpoints, and statistical power to serve as the first of two Phase 3 trials that will lead us to the approval of CF01 for this indication".
The trial will cover 240 patients enrolled at multiple centres, there they will be treated for 24 weeks, comparing 2 doses of CF101 to placebo. The clinical endpoints are an improvement of corneal flurescein staining, tear production and 'dry eye' symptom scores.
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