Biotech Values

[DewDiligence]

The PR is now on GENR’s website:

http://www.genaera.com/pressreleases/May%204,%202004.pdf

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Genaera Initiates Phase II Macular Degeneration Clinical Trial for Squalamine

Plymouth Meeting, PA — May 4, 2004, — 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.
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