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Boston Life Sciences ends Altropane phase 3 trial to evaluate full data set
By Elaine Rigoli
Tampa, Fla., March 20 - Boston Life Sciences, Inc. has notified the Food and Drug Administration that it has elected to terminate its current Special Protocol Assessment and end its phase 3 trial for Altropane earlier than planned in order to analyze the full set of data for efficacy.
No safety issues have been identified in the Parkinson's or Essential Tremor (POET-1) trial, according to a company news release.
About 200 patients have been enrolled in the POET-1 trial, and the company believes it may have already enrolled enough subjects in the trial to evaluate the efficacy of Altropane single photon emission computed tomography imaging in the differentiation of Parkinsonian syndrome tremors from non-Parkinsonian or Essential tremors.
"We based our original plan for enrolling 332 subjects largely because published reports in scientific journals indicated a 20% to 30% misdiagnosis rate in the early stages of Parkinson's disease. In fact, monitoring of the data from subjects enrolled in the POET-1 trial indicates that the error rate by [general practitioners] GPs is much higher. As such, we believe that there is a possibility that the trial may achieve statistical significance with current enrollment, which is just over half the originally planned number of subjects," president and chief operating officer Dr. Mark Pykett said in a statement.
The company said it plans to complete the data analysis and release its findings during the third quarter of 2006.
Hopkinton, Mass.-based Boston Life Sciences develops diagnostic and therapeutic products for central nervous system disorders.
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