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Here are the phase-2 trial designs:

http://biz.yahoo.com/prnews/040422/nyth031a_1.html

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Genaera Plans Phase III Start in Age-Related Macular Degeneration in Early 2005

-FDA Clears IND for Squalamine Trials in Age-Related Macular Degeneration-

-Genaera to Hold Conference Call/Webcast at 11:00 AM Today-

PLYMOUTH MEETING, Pa., April 22 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - News) today announced that the U.S. Food and Drug Administration (FDA) has cleared Genaera's investigational new drug (IND) application for its systemically administered anti-angiogenic drug, squalamine. The IND covers treatment of neovascular diseases of the eye, including subfoveal choroidal neovascularization associated with age-related macular degeneration, known as "wet" AMD. Genaera also announced that they plan to begin Phase II trials in AMD this quarter, and these Phase II trials will run concurrently with the start of Phase III trials in AMD, beginning in early 2005.

"One of Genaera's highest priorities is expediting squalamine's commercialization timeline for wet AMD. We are extremely pleased with the FDA's feedback allowing us to proceed into large-scale clinical trials, including Phase III," commented Roy C. Levitt, MD, President and Chief Executive Officer. "Squalamine has tremendous potential to be a safe, effective, and less invasive anti-angiogenic therapy for this devastating eye disease. At four months after therapy with squalamine, 100% of patients showed stable or improved vision. Our initial Phase I/II clinical trial data including safety and efficacy are comparable or superior to any published or presented results at a similar stage of development for other wet AMD anti-angiogenic therapies, such as Macugen(TM) and Lucentis(TM)."

Dr. Levitt further commented, "Our plans are to focus on first-line therapy for AMD. Genaera expects to complete THREE Phase II clinical trials for squalamine in AMD [emphasis added]. These Phase II trials will be running while we are actively preparing for our anticipated Phase III trials."

The cornerstone of Genaera's Phase II studies is an exploratory trial designed to evaluate the safety and efficacy of squalamine in 100 patients with AMD over a two year period. This Phase II multi-center, randomized, double masked, controlled study will evaluate two dose levels of squalamine (20 mg or 40 mg) given once weekly for four weeks, followed by maintenance doses once every four weeks until week 48. At the end of 48 weeks of therapy, each patient will be followed for 12 months. Analyses from this study are expected to be used in coordinating Phase III activities.

A second exploratory Phase II trial is designed to evaluate the effects of two different doses of squalamine in combination with an initial Visudyne® treatment in 30 patients with AMD. Specifically, this study will evaluate the potential benefits of squalamine pretreatment on the actions of Visudyne® and the added potential benefit of dosing squalamine after Visudyne® to inhibit the potentially detrimental effects of the VEGF 'burst' that commonly occurs after Visudyne® treatment. The multi-center, randomized, controlled, masked study includes monthly squalamine maintenance therapy, and twelve months subsequent follow-up for each patient.

Genaera will also conduct a Phase II pharmacokinetic and safety trial that will evaluate 18 patients with AMD at three different doses of squalamine over four months. In this open-label, parallel group study, squalamine will be administered intravenously at three doses, once weekly for four weeks.

Conference Call

At 11:00 a.m. ET today, Genaera will webcast a conference call hosted by Roy C. Levitt, MD, President and Chief Executive Officer, to discuss Genaera's clinical development plans for squalamine in AMD.

Those who wish to participate in the conference call may telephone [phone] approximately 10 minutes before the start time. A slide presentation will be available on the Internet via Vcall. To access the live or archived call via the Internet, please log onto: http://www.genaera.com or http://www.vcall.com/CEPage.asp?ID=87897. Please connect to the site prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast.

Squalamine Mechanism of Action

Squalamine directly interrupts and reverses multiple facets of the angiogenic process. Working within activated endothelial cells, squalamine inhibits growth factor signaling including VEGF, integrin expression, and reverses cytoskeletal formation, thereby resulting in endothelial cell inactivation and apoptosis. Systemically administered squalamine inhibits abnormal angiogenesis in rodent models of retinopathy of prematurity, and the development of choroidal neovascular membranes in rat models of AMD. Additional preclinical studies have demonstrated that systemic squalamine administration is effective in reaching abnormal ocular blood vessels in primates, and leads to partial regression and inhibition of new abnormal vessels in the eye. These results support that squalamine may have a role in the treatment of human choroidal neovascular membrane formation that underlies the pathology of wet AMD.
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