Genaera Announces Positive Preliminary Data for Evizon for AMD

Genaera has released clinical trial results, including pharmacokinetic data and updated visual acuity outcomes, from a multicenter, open-label, U.S. Phase II clinical trial (MSI-1256F-207) with Evizon for the treatment of choroidal neovascularization associated with age-related macular degeneration (AMD), also known as "wet" AMD.

The company reported interim results from subjects who had received either 10 mg or 40 mg of Evizon (squalamine lactate) as a part of the trial. All patients received four weekly doses of Evizon, with no further maintenance therapy.

Preliminary pharmacokinetics results from six patients treated with 40 mg of Evizon weekly for four weeks suggest that Evizon undergoes biphasic elimination from the circulation with a terminal half-life of roughly seven hours, and no change in kinetics or drug accumulation was observed through week five. All patients receiving the 40 mg dose were diagnosed with wet AMD in both eyes, and had preserved or improved vision during evaluation in both affected eyes through month four including: week three (after two doses of Evizon), week five (one week after the fourth dose, termed end-of-therapy), and at two and four months after initiation of therapy with Evizon. The greatest degree of improvement at four months was a gain relative to baseline of 18 letters, while the greatest degree of loss was 12 letters on the ETDRS chart.

Preliminary results from six patients treated with 10 mg of Evizon, each diagnosed with bilateral wet AMD, demonstrated 90 percent of eyes had preserved or improved vision during evaluation at four months after initiation of therapy. One patient withdrew from therapy on the 10-mg dose after month two, with visual loss of 26 ETDRS letters.

In clinical trials of therapies for wet AMD, gain or loss of less than 15 letters on the ETDRS chart constitutes stable vision, while gain equal to or greater than 15 letters constitutes improved vision. The drug was well-tolerated, with no drug-related serious adverse events occurring in patients involved in this trial.