Genaera Corporation Presents Encouraging Data on Bilateral Visual Acuity in Subjects From EVIZON Phase II TrialsPLYMOUTH MEETING, Pa., March 29 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR) today presented a new subset analysis of EVIZON(TM) (squalamine lactate) clinical data at the IBC Third Annual Ocular Anti- angiogenesis Conference in Cambridge, MA, that suggests the treatment may benefit patients with wet age-related macular degeneration (AMD) whose vision has already significantly deteriorated. In an overview of Phase II clinical trial data, including recently announced 24-week interim results from Study 209 (MSI-1256F-209), Michael J. Gast, M.D., Ph.D., Senior Vice President, Clinical Research and Development, described outcomes for subjects in these studies with fellow affected eyes (i.e., documented disease in the second eye) and poor vision at study entry.
"These data, which are consistent across our Phase I/II program, suggest that intravenous EVIZON safely stabilizes or improves vision in both the study eye and the fellow affected eye in a dose responsive fashion," said Dr. Gast. "What is particularly intriguing is that this effect appears to be most marked in subjects with poorer vision in fellow affected eyes, many of whom, as a result of their low visual acuity, would not currently be considered good candidates for treatment. We look forward to confirming this benefit in ongoing studies."
Dr. Gast reviewed new analyses of fellow affected eyes from Study 207 (MSI-1256F-207), an 18 patient, multicenter, open-label pharmacokinetic trial and from Study 209, a 108 patient, randomized, masked, controlled trial.
In Study 207, mean best corrected visual acuity in fellow affected eyes across all EVIZON dose groups improved over baseline by as many as 8 letters following 4 weekly treatments with EVIZON in subjects with poorer vision (defined as < 50 ETDRS letters at study entry). This effect was also seen in the larger Study 209, where a dose response across EVIZON treatment groups was evident. An analysis of all fellow affected eyes at 24 weeks showed that the 40 mg EVIZON dose improved vision by 4 letters on average from baseline and the 20 mg dose improved vision by approximately 2 letters, with the placebo group declining from baseline by an average of 3 letters. In subjects with very poor vision in the fellow affected eye (defined as < 34 ETDRS letters at study entry), the improvement by dose group was more pronounced. At 24 weeks, best corrected visual acuity in the 40 mg dose group had improved by 8 letters and by more than 5 letters in the 20 mg dose group.
Dr. Gast reported that the potential of EVIZON in fellow eyes would also be carefully evaluated in Study 212 (MSI-1256F-212), a planned, multicenter, randomized, open-label, pharmacodynamic and safety study designed to determine if higher dose levels of EVIZON will produce greater improvements in visual acuity. The study will evaluate four intravenous doses of EVIZON, 40 mg, 80 mg, 120 mg, and 160 mg, over 16 weeks of treatment (4 weekly doses followed by 3 monthly doses). Genaera expects to initiate the study in the second quarter of 2006.
