Alseres Pharmaceuticals has reached agreement with the FDA under the Special Protocol Assessment (SPA) process for the Phase III protocol of Alseres' Altropane molecular imaging agent to aid in the early diagnosis of Parkinsonian syndromes including Parkinson's disease.
A SPA agreement defines the size, design and analysis of clinical trials that will form the primary basis of approval. The Altropane Phase III program, called POET-2 (Parkinson's or Essential Tremor), 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.
Altropane is a molecular imaging agent that specifically and selectively binds to the dopamine transporter (DAT) found on dopamine-producing neurons. Loss of these cells is the hallmark of Parkinson's disease. Altropane used in conjunction with SPECT imaging could be useful to distinguish Parkinsonian from non-Parkinsonian tremor, according to the company.