Boston Life Sciences, Inc. 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.
BLSI's President and Chief Operating Officer, Dr. Mark Pykett, said, "We believe these results will be instrumental in advancing our efforts to sign a commercial partner for ALTROPANE -- a primary business objective for our Molecular Imaging program. We are working with expert advisors and the FDA to determine the most-direct route to FDA approval, and to finalize our plans for POET-2 and the remaining clinical development of ALTROPANE. We plan to provide further guidance to our investors as we gain insight into what further work will be required to seek regulatory approval, including specifics regarding POET-2 and any other studies that may be necessary."
BLSI's Chief Medical Officer, Mark Hurtt, MD, commented, "This is the outcome we anticipated when we ended the POET-1 trial. Our results are particularly encouraging because the readers made their diagnoses based on their evaluations of the ALTROPANE scans alone; they had no access to patient clinical data, such as the age of the patient, in these "fully-blinded" evaluations. In normal practice, nuclear-medicine physicians would evaluate clinical information along with the scans, to further enhance their diagnostic accuracy."
Dr. Alan Waxman of Cedars Sinai Medical Center, a nuclear-medicine expert, a professor at the University of Southern California, and a principal investigator in the POET-1 trial, stated, "We found in our clinic that ALTROPANE was convenient to use, and routinely produced high-quality scans. We were able to complete each patient's testing in about an hour."
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 Single Photon Emission Computed Tomography or SPECT, imaging. Since most forms of Parkinsonian Syndromes result in a decreased number of dopamine-producing cells, it would be expected that these patients also have fewer DATs than do patients without PS. Thus, we believe that ALTROPANE used in conjunction with SPECT imaging could be a useful test to distinguish Parkinsonian Syndrome tremors from non-Parkinsonian tremor: non-Parkinsonian patients would have more ALTROPANE-binding visible in the SPECT image, while Parkinsonian patients would have less.
Boston Life Sciences is traded on the Nasdaq index under the symbol BLSI. BLSI is in active trading today up 1.6% to 3.93 in afternoon trading.
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