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Phase 3 Study of Altropane To Differentiate Parkinsonian From Non-Parkinsonian Tremors

BOSTON--(BUSINESS WIRE)--May 20, 2004--Boston Life Sciences, Inc. (NASDAQ: BLSI - News) announced that the Company has begun the process of patient enrollment in its Phase III trial of Altropane® to differentiate Parkinsonian from non-Parkinsonian tremors. This trial is being carried out under a binding Agreement with the FDA regarding the protocol design. Pursuant to this Agreement, the Company believes that a successful trial (ie, one that meets the endpoints, raises no safety concerns, and complies with the protocol design) will form the basis for the filing of an NDA and the ultimate approvability of Altropane. The trial will enroll approximately 500 subjects and is expected to require approximately 12 months for completion.

"We are looking forward to completing this pivotal study and filing our first NDA as soon as possible thereafter. We believe that Altropane has the potential to meet a growing medical need for an early, objective diagnosis of tremor in the increasing elderly population, which in turn represents a substantial market opportunity for the Company", stated Dr. Marc Lanser, President and Chief Scientific Officer of BLSI. "The accurate differentiation of Parkinsonian from non-Parkinsonian tremors has important clinical implications in terms of initiating effective treatment, minimizing unnecessary treatment side-effects (by reducing the number of inappropriately treated patients), and providing a more accurate prognosis for patients and their families (since Parkinsonian tremors have a relatively poor prognosis compared to non-Parkinsonian tremors). If successful, Altropane would represent the first in a new class of "molecular targeting" diagnostic agents that has the potential ability to assist the clinician in making this important differentiation," added Dr. Lanser.

Source: Boston Life Sciences, Inc.

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