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news.Alseres Pharmaceuticals, a biotechnology company, has reached agreement with the FDA under the special protocol assessment process for the Phase III protocol of the company's Altropane molecular imaging agent to aid in the early diagnosis of Parkinsonian syndromes including Parkinson's disease.
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The Altropane Phase III program, called Poet-2, is designed to confirm the diagnostic utility of Altropane in anticipation of drug registration, and includes two, parallel clinical studies enrolling up to 480 subjects in total.
Thomas Tulip, president of molecular imaging at Alseres, said: “This special protocol assessment (SPA) agreement with the FDA is a key accomplishment for Alseres, providing us with a clear, well-defined path to a marketing application for Altropane.
“The completion of the first stage of our Poet-2 program and this agreement with the FDA markedly reduce our technical and regulatory risk. As a result, we expect expanding interest in all of these ongoing discussions.”