Genaera Corporation has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to squalamine, an intravenously administered, first in class, small molecule anti-angiogenic drug for the treatment of "wet" age-related macular degeneration (AMD).
Under the FDA Modernization Act of 1997, Fast Track drug development programs are designed to expedite the review and facilitate the development of a new drug that demonstrates the potential to address unmet medical needs for the treatment of a serious or life-threatening condition.
"Fast Track status will help accelerate the development and commercialization of squalamine," commented Roy C. Levitt, MD, President and Chief Executive Officer. "This FDA designation recognizes the serious unmet medical need of patients with AMD and the potential of squalamine to affect this disease. All of our Phase II trials for squalamine in AMD are up and running. We anticipate reporting early data from our first Phase II study later this year with additional Phase II data expected, starting in the first half of 2005. We intend to begin Phase III in the first half of 2005 to run concurrently with our largest Phase II trial."
Squalamine is currently being evaluated in three Phase II clinical trials. MSI-1256F-209 is the cornerstone of Genaera's Phase II studies and is 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. Genaera anticipates using data analyses from this study in coordinating Phase III activities.