NYC Healthcare News

Can-Fite BioPharma opens IND with US-FDA for CF101 Phase 3 study in Dry Eye Syndrome

February 27, 2016

The randomized, double-masked trial will compare 2 doses of CF101 to placebo. Approximately 240 patients will be enrolled at multiple centers; they will be treated for 24 weeks. The main outcome assessments (clinical endpoints) are improvement of corneal fluorescein staining (which is a measure of ocular surface inflammation), tear production, and dry eye symptom score.

Dry Eye Syndrome affects a large proportion of the general population, including contact lens users and postmenopausal women, and is also associated with Rheumatoid Arthritis. Based on published data, Dry Eye Syndrome affects more than 30 million people in the US alone, and the market for a safe and effective treatment is estimated at US$ 2 billion. Can-Fite entered the development of CF101 for this indication after learning that, during a Phase 2a rheumatoid arthritis trial, several patients reported a significant improvement in their Dry Eye Symptoms following treatment with CF101 as a monotherapy.