Healthcare Industry News: computed tomography
News Release - March 20, 2006
Boston Life Sciences Ends ALTROPANE(R) POET-1 Phase III Trial Early to Evaluate Full Data SetCompany Believes Trial May Have Already Enrolled Enough Subjects to Achieve Statistical Significance
HOPKINTON, Mass., March 20 (HSMN NewsFeed) -- Boston Life Sciences, Inc. (Nasdaq: BLSI ), a development-stage biotechnology company focused on diagnostic and therapeutic products for diseases of the central nervous system, has notified the U.S. Food and Drug Administration (FDA) that it has elected to terminate its current Special Protocol Assessment (SPA) and end its Phase III, Parkinson's or Essential Tremor (POET-1) trial for ALTROPANE earlier than planned in order to analyze the full set of data for efficacy. No safety issues have been identified in this trial. Based on the previous performance of ALTROPANE and BLSI's monitoring of non-blinded data from the approximately 200 patients enrolled in the POET-1 trial to date, the company believes it may have already enrolled enough subjects in the trial 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.
"Our goal with the POET-1 trial was to assess whether ALTROPANE imaging is more effective than the subjective methods used by general practitioners (GP) and internists to distinguish between tremors caused by Parkinsonian Syndrome and those associated with other disorders, as judged by comparison to the 'gold standard' -- diagnosis by a Movement Disorder Specialist (MDS)," said BLSI's President and Chief Operating Officer, Dr. Mark Pykett. "We based our original plan for enrolling 332 subjects largely because published reports in scientific journals indicated a 20- to 30-percent 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."
Dr. Pykett continued, "Our main business objectives with the ALTROPANE program are the successful completion of the registration process as soon as possible and the engagement of a world-class partner as we work toward bringing our portfolio of molecular imaging products to market. Because we are precluded from analyzing the data on the performance of ALTROPANE imaging while the trial is ongoing, we believe that the most-efficient way to achieve these goals is to stop the trial so we can review the ALTROPANE imaging results along with the rest of the trial data to confirm the performance of ALTROPANE, and determine how it fared when compared to both an MDS diagnosis and that of a GP."
According to BLSI Chief Medical Officer, Dr. Mark Hurtt, the company anticipates completing the data analysis and releasing its findings during the third quarter of 2006. "Once we have reviewed all the data from the POET-1 trial, we plan to provide a public update on the results of POET-1. At that time, we will also outline our strategy for POET-2 and the overall clinical development plan for the ALTROPANE program."
About ALTROPANE Imaging Agent and Parkinsonian Syndromes (PS) Including Parkinson's Disease
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. 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.
There are several conditions that are considered Parkinsonian Syndromes. Parkinson's Disease is the most common form of Parkinsonian Syndrome. Other less common Parkinsonian Syndromes include multiple system atrophy (MSA), Progressive Supranuclear Palsy (PSP), and drug-induced Parkinsonism.
Experts estimate that, each year, approximately 140,000 individuals present to their physician with new, undiagnosed movement disorders such as Parkinson's Disease and Essential Tremor. In 2002, the European Journal of Neurology reported that there is a 20- to 30-percent misdiagnosis rate in the early stages of Parkinson's disease. Other publications have reported even higher rates of misdiagnosis. We believe that the accurate differentiation of Parkinsonian from non-Parkinsonian tremors has important clinical implications. Physicians may be able to initiate earlier referral for specialty care, prescribe effective treatments, and provide a more-informed prognosis for patients and their families. If these trials are successful and the drug is approved, we believe that ALTROPANE could be a highly-selective CNS diagnostic molecular imaging agent -- a valuable tool to help clinicians make better, more-accurate diagnoses.
About Boston Life Sciences, Inc.
Boston Life Sciences, Inc. (BLSI) is engaged in the research and clinical development of diagnostic and therapeutic products for central nervous system (CNS) disorders. ALTROPANE is in Phase III clinical trials for the diagnosis of Parkinsonian Syndrome (PS) and a Phase II clinical trial for the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). The Company's research and pre-clinical CNS programs include Inosine for the treatment of stroke, O- 1369 for the treatment of Parkinson's disease and FLUORATEC(TM), a second generation molecular imaging agent, for PS and ADHD. BLSI's current research collaborations include Harvard Medical School, Children's Hospital of Boston and the University of Massachusetts-Worcester.
ALTROPANE is a registered trademark of Boston Life Sciences, Inc.
The foregoing release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward- looking statements include statements regarding Boston Life Sciences' expectations, beliefs, intentions or strategies regarding the future, including the Company's clinical trials for ALTROPANE, the prospects of FDA approval of ALTROPANE and the commercialization, including partnering opportunities, of ALTROPANE. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including those risks, uncertainties and factors referred to in the Company's Quarterly Report on form 10-Q for the quarter ended September 30, 2005, filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Boston Life Sciences from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Boston Life Sciences, Inc. is providing the information in this press release as of this date and does not undertakes any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Source: Boston Life Sciences
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