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Wednesday
Findings from Review of POET-1 Study of ALTROPANE(R) Molecular Imaging Agent (CLICK FOR MORE):
"Boston Life Sciences, Inc. BLSI today reported statistically significant results for the Primary Endpoint from the POET-1 (Parkinson's or Essential Tremor) trial for the ALTROPANE molecular imaging agent. The POET-1 trial was designed to assess whether ALTROPANE imaging is more accurate than the clinical diagnosis of primary care physicians (PCP) to distinguish between tremors caused by Parkinsonian Syndrome and those associated with other disorders, as judged by comparison to a definitive diagnosis by Movement Disorder Specialists (MDS). ALTROPANE scans showed statistically significant superiority over the diagnosis of PCPs on measures of both specificity and sensitivity, the Primary Endpoint of the trial. Based on data analyzed to date, with the exception of one 'possibly-related' urinary tract infection that resolved after treatment, there were no drug-related serious adverse events. In order to avoid potential bias to further clinical development of ALTROPANE and in keeping with FDA guidance to the Company, detailed results of the trial cannot be disclosed at this time.
As previously announced in March 2006, the Company ended the POET-1 trial early with approximately 30 percent fewer patients than originally specified because non-blinded data indicated that the error rate of general practitioners in the trial was higher than had been anticipated in the trial design..."
"Boston Life Sciences, Inc. BLSI today reported statistically significant results for the Primary Endpoint from the POET-1 (Parkinson's or Essential Tremor) trial for the ALTROPANE molecular imaging agent. The POET-1 trial was designed to assess whether ALTROPANE imaging is more accurate than the clinical diagnosis of primary care physicians (PCP) to distinguish between tremors caused by Parkinsonian Syndrome and those associated with other disorders, as judged by comparison to a definitive diagnosis by Movement Disorder Specialists (MDS). ALTROPANE scans showed statistically significant superiority over the diagnosis of PCPs on measures of both specificity and sensitivity, the Primary Endpoint of the trial. Based on data analyzed to date, with the exception of one 'possibly-related' urinary tract infection that resolved after treatment, there were no drug-related serious adverse events. In order to avoid potential bias to further clinical development of ALTROPANE and in keeping with FDA guidance to the Company, detailed results of the trial cannot be disclosed at this time.
As previously announced in March 2006, the Company ended the POET-1 trial early with approximately 30 percent fewer patients than originally specified because non-blinded data indicated that the error rate of general practitioners in the trial was higher than had been anticipated in the trial design..."