FDAnews
www.fdanews.com/articles/73138-genaera-reaches-target-enrollment-in-evizon-phase-ii-trial

Genaera Reaches Target Enrollment in Evizon Phase II Trial

June 8, 2005

Genaera has reached the target enrollment for its third U.S. Phase II clinical trial in "wet" age-related macular degeneration (AMD).

The company has enrolled 100 patients in a multicenter, randomized, double-masked, controlled, U.S. Phase II clinical trial (MSI-1256F-209) with Evizon (squalamine lactate) for the treatment of choroidal neovascularization associated with AMD.

Evizon is a systemically delivered antiangiogenic drug being developed to treat AMD. MSI-1256F-209 is the largest of Genaera's three Phase II studies. It will evaluate the safety and efficacy of Evizon in all subtypes of wet AMD over a two-year period and is designed to run concurrently with Phase III trials.

This Phase II study will evaluate two dose levels of Evizon (20 mg or 40 mg) given once weekly for four weeks, followed by maintenance doses once every four weeks until Week 48. At the end of 48 weeks of therapy, each patient will be followed for a further 12 months.