One of the studies, MSI-1256F-208, is a phase II trial designed to evaluate the effects of three different doses of squalamine in combination with an initial Visudyne treatment. Specifically, this study will evaluate the safety and effects of systemically administered squalamine before and after photodynamic therapy with Visudyne. The company has enrolled 45 patients in this trial.
Genaera Corporation also announced that it had completed enrollment in a multi-center open-label US pharmacokinetics and safety phase II clinical trial, MSI-1256F-207. This trial will evaluate 18 patients with age-related macular degeneration (AMD) at three different doses of squalamine over four months.
Squalamine is the leading systemically delivered anti-angiogenic drug being developed to treat AMD. Enrollment in the MSI-1256F-208 trial will continue through February 2005 in order to accept patients still in screening.
“Reaching target enrollment for Trials 208 and 207 is a significant step in our development and commercialization plan for squalamine,” commented Dr Roy Levitt, president and CEO of Genaera. “We anticipate reporting preliminary data from both of these studies at key ophthalmology meetings as early as the first-half of this year.”
Levitt also stated that the company remains on track to initiate phase III trials in the first half of 2005 to run concurrently with the phase II studies.