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news.Boston Life Sciences has elected to end its phase III, "Parkinson's or essential tremor" trial for its imaging agent Altropane earlier than planned in order to analyze the full set of data for efficacy.
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Based on the previous performance of Altropane and Boston’s monitoring of non-blinded data from the approximately 200 patients enrolled in the current trial, the company believes it may have already enrolled enough subjects to evaluate the efficacy of Altropane single photon emission computed tomography (SPECT) imaging in the differentiation of Parkinsonian syndrome tremors from non-Parkinsonian or Essential tremors.
Altropane is a molecular-imaging agent that specifically binds to the dopamine transporter (DAT) protein found on the surface of dopamine-producing neurons, making it visible during SPECT imaging.
“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 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”, said Boston Life Sciences’ president and COO, Dr Mark Pykett.