GENAERA ENDS DEVELOPMENT OF WET AMD DRUG

Genaera has announced that, following a comprehensive review of its development portfolio and external market conditions, its board of directors and management have determined that it is in the best interest of the company to terminate the Evizon (squalamine lactate) clinical development program in wet age-related macular degeneration (AMD).

Genaera had been pursuing a multi-center, randomized, open-label Phase II study (Study 212) of Evizon to determine if higher dose levels would produce greater and more rapid improvements in visual acuity than those seen in prior Phase II studies, a result considered a necessary prerequisite to Phase III development, successful registration and partnership opportunities. The rapid acceptance, both domestically and abroad, of new and off-label products that improve vision in wet AMD significantly curtailed the rate of subject enrollment in Study 21, according to the company.

"Despite our extensive recruiting efforts, enrollment of Study 212 has remained extremely difficult," Jack Armstrong, president and CEO of Genaera, said. "Additionally, preliminary information from investigators on patients enrolled to date in Study 212 suggests that Evizon is unlikely to produce vision improvement with the speed or frequency necessary to compete with recently introduced treatments."

In light of this development, the company now plans to focus on the development of trodusquemine (MSI-1436) for the treatment of obesity. The company anticipates initiating a Phase I clinical study of trodusquemine in the first half of 2007. Trodusquemine is a centrally acting appetite suppressant that has been shown to cause weight loss and normalize both fasting blood glucose and blood cholesterol levels in animal models of obesity. In vivo and in vitro studies with trodusquemine support a mixed mechanism of action, which includes selective inhibition of protein tyrosine phosphatase 1B.