Can-Fite Announces Positive Results From Its Phase II Trial Treating Keratoconjunctivitis Sicca (Dry Eye Syndrome) With CF101
Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, an Israeli Biopharmaceutical company, announced today that its 80-patient Phase II clinical study using CF101 to treat patients with moderate to severe Dry Eye Syndrome had successfully met the primary efficacy endpoint. Patients in this masked study were randomly assigned to either 1 mg of CF101 or matching placebo; drug was taken orally as a monotherapy for 12 weeks. The 12 week duration is one that Can-Fite has used in other trials of CF101 as an anti-inflammatory agent, and is similarly a common one for Phase II trials of Keratoconjunctivitis Sicca. The patient group receiving CF101 demonstrated statistically significant improvement in superficial punctate keratitis, relative to the placebo group, as measured by fluorescein staining. This sensitive and prevalent measure of corneal disease was prospectively defined as a primary study endpoint, thus demonstrating the ability of orally administered CF101 to exert beneficial effects on ocular surface inflammation. An improvement in additional study parameters was also observed. CF101 was safe and well tolerated during the study period.
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