Genaera Corporation has initiated the first of two planned global Phase III clinical trials (MSI-1256F-301) of its systemically administered anti-angiogenic drug, Evizon (squalamine lactate), for the treatment of “wet” age-related macular degeneration (AMD).
Genaera plans two identical international Phase III studies designed to enroll subjects with predominantly classic, minimally classic and occult forms of wet AMD. Each study will be a multi-center, randomized, double-masked, controlled trial and will evaluate two systemicallyadministered doses of Evizon (40mg and 20 mg) versus placebo, dosed weekly for four weeks followed by maintenance doses every four weeks until week 104.
Photodynamic therapy with Visudyne (PDT) (QLT Inc., Vancouver, Canada) will be allowed for all subjects if deemed necessary by the study physician. The total number of subjects enrolled into each Phase III study will be based upon analyses of data from the Company’s existing and ongoing Phase II clinical trials, as agreed upon with the US FDA. The Company anticipates launching its second Phase III trial (MSI-1256F-302) in the second half of 2005.
The primary objectives of these studies are to demonstrate safety and significant clinical benefit of Evizon therapy on visual acuity at one year in the study eye (assessed by Early Treatment Diabetic Retinopathy scoring System or ETDRS).
“Roy C. Levitt, President and CEO of Genaera says, “Based on our clinical testing to date, Evizon has stabilized or improved vision with a good safety profile in most everyone we have treated, including subjects with two affected eyes. We look forward to demonstrating in these studies the numerous advantages of systemic delivery of Evizon, which is noninvasive to the eye, including the potential to treat the commonly affected fellow eye.
Ultimately, as the leading systemic anti-angiogenic investigative new drug in development for the treatment of wet AMD, we expect to verify the great potential Evizon has to be a leading therapy in the rapidly growing AMD market.”
Genaera is currently conducting three Phase II trials of Evizon in wet AMD at multiple sites throughout the United States. In October 2004, the FDA granted Evizon Fast Track designation. In January 2005, the FDA selected Evizon for participation in the Continuous Marketing Application (CMA) Pilot 2 programme.