The company has enrolled 100 patients in a multi-center, randomized, double-masked, controlled, US phase II clinical trial with Evizon (squalamine lactate) for the treatment of choroidal neovascularization associated with “wet” age-related macular degeneration (AMD).
This trial is the largest of Genaera’s three phase II studies. It will evaluate the safety and efficacy of Evizon in all subtypes of “wet” AMD over a two-year period and is designed to run concurrently with phase III trials.
This phase II study will evaluate two dose levels of Evizon (20mg or 40mg) 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 a further 12 months.
“Based on clinical trial results reported thus far, we are encouraged as we move further into this long-term trial and cornerstone of our phase II clinical program. Analyses from the 209 Trial will be used to coordinate our phase III activities including determining the final sample size. We remain confident phase III trials will begin this quarter,” commented Dr Roy Levitt, president and CEO of Genaera.