GENAERA REPORTS EVIZON STUDY DATA

Genaera Corporation has reported that an exploratory, multicenter, randomized, double-masked Phase II clinical trial (MSI-1256F-208) of Evizon (squalamine lactate) in 45 subjects met its primary goal of demonstrating safety when dosed concomitantly with photodynamic therapy with Visudyne (PDT). Evizon with concomitant PDT was well-tolerated in all subjects with no drug-related serious adverse events reported to date. The most common adverse events involved infusion site reactions. These events were generally mild and were distributed evenly across the Evizon plus PDT treatment groups.

Evizon is intended to treat wet-age macular degeneration. Preliminary analyses showed that subjects treated with 40 mg Evizon plus PDT at 29 weeks had a slight increase in mean visual acuity compared to visual acuity at study entry, an important secondary endpoint, while the PDT-alone group demonstrated a decrease in mean visual acuity from baseline to 29 weeks. Moreover, approximately 90 percent of subjects maintained vision (defined as a gain or loss of less than 15 letters in visual acuity) when treated with 40 mg of Evizon plus PDT. Additionally, of the subjects treated with the combination of 40 mg of Evizon plus PDT, 10 percent required a second PDT treatment compared to 47 percent of those in the PDT-alone arm.