GENAERA REPORTS POSITIVE PRELIMINARY TWO-MONTH DATA FROM PHASE II STUDY FOR SQUALAMINE

Genaera has announced positive preliminary clinical results, including improved vision, from a multicenter open-label U.S. Phase II clinical trial (MSI-1256F-207) with squalamine for the treatment of choroidal neovascularization associated with age-related macular degeneration (AMD), also known as "wet" AMD.

Squalamine is the leading systemically delivered anti-angiogenic drug being developed to treat AMD.

Preliminary results from six patients treated with 40 mg of squalamine, each of whom suffered from wet AMD in both eyes, demonstrated that 100 percent of eyes had preserved or improved vision at week three (after two doses of squalamine), week five (end of therapy) and two months after initiation of therapy. The greatest degree of improvement at two months was a gain relative to baseline of 28 letters (5.6 lines), while the greatest degree of loss was 11 letters on the ETDRS chart.

In clinical trials of therapies for wet AMD, gain or loss of less than 15 letters (three lines) on the ETDRS chart constitutes stable vision, while gain equal to or greater than 15 letters constitutes improved vision. All patients received four weekly doses of squalamine, with no further maintenance therapy. There have been no withdrawals from therapy or drug-related serious adverse events in the trial thus far.