Alseres completes enrollment in first stage of Phase III Parkinson's program

Published: 06-Feb-2009

Alseres Pharmaceuticals, a biotechnology company, has completed enrollment in the first stage of the Altropane Parkinson's or essential tremor Phase III clinical program.

The objective of the first part of the program was to acquire the set of Altropane images which will be used to train expert readers for the Phase III registration portion of the program. The Altropane molecular imaging agent is being developed by Alseres to aid in the early diagnosis of Parkinsonian syndromes.

The Phase III (Poet-2) program is a two-stage registration program, the first stage of which was a clinical study designed to enroll up to 60 subjects with early stage tremor in seven US medical centers. As is the customary practice for clinical trials of molecular imaging agents, the study was designed to acquire the set of Altropane images which will be used to train the expert nuclear medicine readers.

The second stage of the planned Poet-2 program will involve two concurrent, replicate, multi-center Phase III registration trials which will be conducted at 30-40 medical facilities throughout the US.

Thomas Tulip, president of molecular imaging at Alseres, said: We are pleased to have reached this milestone in our Poet-2 program. We are working with the FDA on the final design of our Phase III registration trials for which we expect to begin enrollment in 2009. The results from the Poet-2 program and data from more than 600 previous subjects will be included in the submission of a new drug application, projected for 2011.

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