Genaera: interim phase 2 study results show Evizon for AMD to be safe

By Lisa Kerner

Erie, Pa., March 1 - Genaera Corp. said data from a 24-week interim analysis of its phase 2 trial of Evizon (squalamine lactate) for the treatment of "wet" age-related macular degeneration (AMD) showed that at 24 weeks of therapy, the 40 mg dose of Evizon was safe and well tolerated.

Vision was stabilized in both the study eyes and the fellow affected eyes of the majority of subjects, according to a company news release.

In study eyes, Evizon improved or stabilized vision (defined as a loss of less than 15 letters in visual acuity) in 83% of subjects receiving the 40 mg dose, compared to 71% of subjects in the control group.

In the fellow affected eye 40 mg group, 11% had a gain in visual acuity of 15 letters or more, compared with 7% of subjects in the 20 mg group.

The phase 2 randomized, multi-center, double-masked, controlled clinical trial of 108 subjects is designed to assess the safety of two doses of Evizon (40 mg and 20 mg) and their effect on visual acuity. Treatment is administered intravenously once a week for four weeks and monthly thereafter, with photodynamic therapy as background therapy allowed at the discretion of the investigator.

Nearly half of the subjects had active occult disease and about 60% had a fellow affected eye.

The most frequently reported treatment-related adverse events in the 24-week interim analysis were infusion site reactions, which were dose related and consistent with adverse events reported in prior studies, according to the release.

"These data from our first controlled study of intravenous Evizon as monotherapy for the treatment of wet AMD confirm previous safety experience and demonstrate dose response and efficacy signals in both the study and fellow affected eyes," president and chief executive officer Jack Armstrong said in the release.

"Additionally, the data suggest, as we suspected, that doses higher than 40 mg may produce greater improvements in visual acuity."

Genaera said it is planning an additional phase 2 multi-center, randomized, open label, pharmacodynamic and safety study designed to evaluate four dose levels of Evizon (40 mg, 80 mg, 120 mg and 160 mg) in 36 subjects over 16 weeks of treatment. The study is expected to begin in the second quarter of 2006.

Genaera develops products to address substantial unmet medical needs including eye, cancer and respiratory disorders. The company is located in Plymouth Meeting, Pa.

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