Phase II trials are beginning, although no PR from GENR......
May 04, 2004 08:05:00 (ET)
PLYMOUTH MEETING, Pa., May 4, 2004 /PRNewswire-FirstCall via COMTEX/ -- Genaera Corporation (GENR, Trade) 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."