Blind World

Macular Degeneration.
Genaera Initiates Phase II Macular Degeneration Clinical Trial for Squalamine.

May 4, 2004.

Press Release.

Genaera Corporation (Nasdaq: GENR) today announced the opening of enrollment for the first U.S. Phase II clinical trial of its systemically administered anti-angiogenic drug, squalamine, for the treatment of the "wet" age-related macular degeneration (AMD). This pharmacokinetic and safety trial is designed to evaluate 18 patients with "wet" AMD at three different doses of squalamine. In this open-label, parallel group study; squalamine will be administered intravenously at three doses, once a week for four weeks and all patients will be followed for up to four months. The study will be performed at leading ophthalmic centers in the United States. "As we recently announced, Genaera intends to conduct three Phase II clinical trials for squalamine in AMD and begin Phase III trials in early 2005," commented Roy C. Levitt, MD, President and Chief Executive Officer. "This study marks the first step in our expedited development plan for squalamine in ophthalmic indications."

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.

About AMD Angiogenesis resulting from AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. About 25-30 million people are affected globally. This number is expected to triple over the next 25 years. AMD occurs in two types: the "dry" form and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels, or choroidal neovascularization, under the central part of the retina, the macula. Dry AMD, or the avascular form is the more common and milder form of AMD, accounting for 85% to 90% of all cases. Dry AMD results in varying forms of sight loss and may or may not eventually develop into the wet form. Although the wet form of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight loss is much greater. It is responsible for 90% of severe vision loss associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed annually worldwide. In North America alone, approximately 200,000 new cases of wet AMD are diagnosed each year. Wet AMD is caused by the growth of abnormal blood vessels, or choroidal neovascularization, under the central part of the retina, the macula.

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