Second part of phase 2 glaucoma study approved in Bulgaria
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Regulatory authorities in Bulgaria approved patient enrollment for the second cohort of a phase 2 clinical study in glaucoma, Can-Fite BioPharma and OphthaliX announced in a press release.
In the first cohort study, patients were treated with 1 mg CF101, an A3 adenosine receptor agonist that acts as a neuroprotective agent and prevents apoptosis of retinal ganglion cells, or placebo. Masked results showed that CF101 had a favorable safety profile and was well-tolerated, the release said. A previous ophthalmic study showed CF101 lowered IOP.
In the second cohort, patients will be randomized to receive 2 mg of CF101 or placebo every 12 hours for 16 weeks. Study data are expected in the second half of 2015.
OphthaliX retains exclusive rights for the use and development of CF101, which includes a U.S. patent for the reduction of IOP that expires in 2030, the release said.