Genaera begins phase III clinical trial for squalamine lactate

Genaera Corp. said it initiated the first of two planned global phase III clinical trials for squalamine lactate (Evizon), a possible treatment for wet age-related macular degeneration (AMD).

These studies hope to demonstrate safety and significant clinical benefit of this anti-angiogenic drug on visual acuity at 1 year in the study eye as assessed by the Early Treatment of Diabetic Retinopathy Study scoring system, the company said. Planned secondary analyses include evaluation of changes in visual acuity from baseline in the study eye at year 2, change in visual acuity in fellow eyes affected with wet AMD, and quality of life at years 1 and 2.

The total number of subjects enrolled in each phase III study will be based upon data analyses from the company's existing and ongoing phase II clinical trials, as agreed upon with the FDA.

The two identical phase III studies will enroll subjects with predominantly classic, minimally classic, and occult forms of wet AMD. Each study will be a multicenter, randomized, double-masked, controlled trial and will evaluate two systemically administered doses of squalamine lactate (40 and 20 mg) versus placebo.

The drug will be dosed weekly for 4 weeks, followed by maintenance doses every 4 weeks until week 104. Photodynamic therapy with verteporfin (Visudyne, Novartis Ophthalmics and QLT Inc.) will be allowed for all subjects if deemed necessary by the study physician.

Genaera said it plans to launch its second phase III trial later this year.