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>>UPDATE - Genaera to start blindess drug trial in early '05
Thursday April 22, 8:44 am ET
Reuters

(Adds details paragraphs 4-10)

NEW YORK, April 22 (Reuters) - Genaera Corp. (NasdaqSC:GENR - News) said on Thursday it expects by early 2005 to begin late-stage clinical trials of an experimental drug to treat macular degeneration, the leading cause of blindness among the elderly.

The company said it made the decision after getting clearance from the U.S. Food and Drug Administration (News - Websites) for plans to conduct its first clinical trials of the drug, squalamine, in the United States, and after discussions with the agency about its expedited trial plans.

Genaera will begin additional mid-stage, or Phase II, trials during the current quarter and Phase III trials early next year while the earlier study is still underway.

"We are extremely pleased with the FDA's feedback allowing us to proceed into large-scale clinical trials, including Phase III," said Genaera Chief Executive Roy Levitt of the plan that could help cut down on the time it will take to get the drug on the market.

The tiny Pennsylvania biotechnology company last August released promising results from a small, early-stage trial of squalamine that was conducted in Mexico.

The trial tested the treatment against the wet form of macular degeneration, a disorder that can strike as people age and lead to blindness and that is more severe than a so-called "dry" form of the disease.

Squalamine, which demonstrated improvement or no deterioration of vision in 97 percent of the 40 patients in the early-stage study, is administered intravenously.

About 500,000 new cases of the wet form of age-related macular degeneration are diagnosed annually worldwide and that number is expected to rise as the baby-boom generation ages.

Age-related macular degeneration drugs in later stages of development by Pfizer Inc. (NYSE:PFE - News) in partnership with Eyetech Pharmaceuticals Inc. (NasdaqNM:EYET - News) and another by Genentech (NYSE:DNA - News) are delivered by injection directly into the eye.

All three drugs are known as anti-angiogenesis drugs that work by cutting off nutrients to the abnormal blood vessels that grow beneath the retina, causing the loss of eyesight. <<