NEW YORK (MarketWatch) -- Genaera Corp. said Monday it reached an agreement on a special protocol assessment with the Food and Drug Administration for the design of two global Phase III clinical trials evaluating Evizon, or squalamine lactate, for the treatment of choroidal neovascularization associated with age-related "wet" macular degeneration. This assessment is a binding written agreement between Genaera and the FDA that the clinical protocols for the planned Phase III trials are adequate to meet scientific and regulatory requirements to form the primary basis for efficacy claims in a new drug application for Evizon. "We are very pleased to have sought and reached agreement with the FDA on the design of our Phase III trials of EVIZON in wet AMD," said Roy C. Levitt, MD, President and Chief Executive Officer of Genaera. "The SPA is an important milestone in our aggressive clinical development plans for EVIZON and solidifies our regulatory pathway towards FDA approval. With this SPA in hand we are ready to begin our registration trials in the very near future."
The two identical international Phase III studies are designed to enroll patients 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 systemically-administered doses of EVIZON (40 mg and 20 mg) versus placebo, dosed weekly for four weeks followed by maintenance doses every four weeks until week 104. Photodynamic therapy (PDT) will be allowed for all patients if deemed necessary by the study physician. The total number of patients 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 FDA. 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). Planned secondary analyses include evaluation of changes in visual acuity from baseline in the study eye at year two, change in visual acuity in fellow eyes affected with wet AMD, and quality of life. "In our early Phase I and II trials EVIZON has stabilized or improved vision in most everyone we have treated, including patients with two affected eyes, with a good safety profile", commented Dr. Levitt. "We look forward to confirming these results by demonstrating a statistically significant clinical benefit in these upcoming large scale registration trials of EVIZON. Additionally, we intend to demonstrate 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 hope to reveal the great potential EVIZON has to be a leading therapy in the rapidly growing AMD market."
Is it my Monday mornin' brain or is there somethin' not right in this PR..GENR reports SPA for squalamine..studying 3 different populations, 2 different doses, photodynamic therapy allowed..primary endpoint is safety and "significant clinical benefit at one year"<what is their defintion agreed upon with FDA?>, secondaries include benefit at 2 years for study eye and 'fellow eye's' with wet AMD condition..
<the 2 other types don't get measured?>
How is the investor supposed to assess this? Should investor assume there are prespecified stratifications of all the groups, dosages, photodynamic therapy patients?
No position..posted on INGN board of all places.. |
