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15.08.2005 18:52:00
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Boston Life Sciences and the FDA Reach Agreement on a New SPA for the Pivotal Phase III Program for ALTROPANE(R) Molecular Imaging Agent
Boston Life Sciences, Inc. (NASDAQ: BLSI) announced today that, atthe request of the company, the US Food and Drug Administration (FDA)granted a new Special Protocol Assessment (SPA) for ALTROPANE(R), theCompany's molecular imaging agent that is being developed to aid inthe differentiation of Parkinsonian Syndrome (PS) tremor fromnon-Parkinsonian tremor. Under the terms of this agreement with theFDA, the Company may conduct two smaller Phase III trials, POET-1 andPOET-2, rather than one large Phase III trial without sacrificing itsSPA status and will be permitted to include all subjects currentlyenrolled in the existing Phase III clinical trial pursuant to therevised protocol. In addition, the Company has reduced its statisticalendpoint threshold from p<0.02 to p<0.05 for both studies.
"Naturally I am delighted with this accomplishment," stated BLSIChairman Peter Savas. "It's the product of a broader effort on ourpart to better position our programs and assets for development,approval and commercialization."
The Company's President Dr. Mark Pykett added, "We believe thisnew agreement with the FDA is beneficial in three ways. First andforemost, we significantly lowered our statistical endpointrequirement from p<0.02 to p<0.05. Second, we retained our SPA statuswithout losing the benefit of the patients that have been enrolled todate. Third, we abbreviated the time and cost of completing theongoing Phase III study. As a result, we may be in a position toadvance partnering opportunities earlier than expected."
About the "Parkinson's or Essential Tremor" (POET-1) Trial
BLSI's pivotal ALTROPANE Phase III trial is a multi-center,open-label, out-patient, clinical trial that will include both maleand female patients between the ages of 18 and 80 and is designed todemonstrate the efficacy of ALTROPANE used with single photon emissioncomputed tomography (SPECT) imaging in the differentiation ofParkinsonian Syndrome tremors from non-Parkinsonian or Essentialtremors. Patients from this trial are referred by an internist,general practitioner or neurology clinic and, subsequent to SPECTimaging, will also be diagnosed by a Movement Disorder Specialist. Formore information about the POET trial, e-mail BLSI attrials@bostonlifesciences.com.
About ALTROPANE Imaging Agent and Parkinsonian Syndromes (PS)Including Parkinson's Disease
ALTROPANE is a radiolabeled (123I) molecular imaging agent thatbinds with high affinity and specificity to the dopamine transporter(DAT), a protein found on the surface of dopamine producing neurons.Since most forms of Parkinsonian Syndromes result in a decreasednumber of dopamine producing cells it would be expected that thesepatients also have fewer DATs. As a result, when administered topatients with PS, ALTROPANE binding is substantially diminished ascompared to patients without PS. We believe this marked decrease inALTROPANE binding in patients with PS is the basis for the clinicalutility of a molecular imaging test for distinguishingnon-Parkinsonian tremors from Parkinsonian Syndrome tremors.
Several non-discrete conditions are included in ParkinsonianSyndromes. Parkinson's Disease is the most common form of ParkinsonianSyndrome. Other less common Parkinsonian Syndromes include multiplesystem atrophy (MSA), Progressive Supranuclear Palsy (PSP) anddrug-induced Parkinsonism.
It is estimated that approximately 140,000 individuals per yearpresent to their physician with new, undiagnosed movement disorderssuch as Parkinson's Disease and Essential Tremor. In 2002, theEuropean Journal of Neurology reported that there is a 20-30%misdiagnosis rate in the early stages of Parkinson's disease. Otherpublications have reported even higher rates of misdiagnosis. Webelieve that the accurate differentiation of Parkinsonian fromnon-Parkinsonian tremors has important clinical implications in termsof initiating effective treatment, minimizing unnecessary treatmentside-effects (by reducing the number of inappropriately treatedpatients), and providing a more accurate prognosis for patients andtheir families (since Parkinsonian tremors have a relatively poorprognosis compared to non-Parkinsonian tremors). If these trials aresuccessful and the drug approved, we believe that ALTROPANE wouldrepresent the first in a new class of highly-selective CNS diagnosticmolecular imaging agents that has the potential ability to assist theclinician in making this important differentiation.
About Boston Life Sciences, Inc.
Boston Life Sciences, Inc. (BLSI) is engaged in the research andclinical development of diagnostic and therapeutic products forcentral nervous system (CNS) disorders. ALTROPANE is in Phase IIIclinical trials for the diagnosis of Parkinsonian Syndrome (PS) and aPhase II clinical trial for the diagnosis of Attention DeficitHyperactivity Disorder (ADHD). The Company's research and pre-clinicalCNS programs include Inosine for the treatment of stroke, O-1369 forthe treatment of Parkinson's disease and FLUORATEC(TM), a secondgeneration molecular imaging agent, for PS and ADHD. BLSI's currentresearch collaborations include Harvard Medical School, Children'sHospital 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 statementswithin the meaning of the Private Securities Litigation Reform Act of1995. Forward-looking statements include statements regarding BostonLife Sciences' expectations, beliefs, intentions or strategiesregarding the future, including the Company's Phase II and Phase IIIclinical trials for ALTROPANE, the prospects of FDA approval ofALTROPANE and the commercialization, including partneringopportunities, of ALTROPANE. Forward-looking statements can beidentified by terminology such as "anticipate," "believe," "could,""could increase the likelihood," "estimate," "expect," "intend," "isplanned," "may," "should," "will," "will enable," "would be expected,""look forward," "may provide," "would" or similar terms, variations ofsuch terms or the negative of those terms. Such forward-lookingstatements involve known and unknown risks, uncertainties and otherfactors including those risks, uncertainties and factors referred toin the Company's Quarterly Report on form 10-Q for the quarter endedMarch 31, 2005, filed with the Securities and Exchange Commissionunder the section "Risk Factors," as well as other documents that maybe filed by Boston Life Sciences from time to time with the Securitiesand Exchange Commission. As a result of such risks, uncertainties andfactors, the Company's actual results may differ materially from anyfuture results, performance or achievements discussed in or implied bythe forward-looking statements contained herein. Boston Life Sciences,Inc. is providing the information in this press release as of thisdate and does not undertakes any obligation to update anyforward-looking statements contained in this press release as a resultof new information, future events or otherwise.
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