Boston Life Sciences Commences Phase III Study of Altropane; Study designed to differentiate Parkinsonian from non-Parkinsonian tremors.

Business Editors/Health/Medical Writers

BOSTON--(BUSINESS WIRE)--May 20, 2004

Boston Life Sciences, Inc. (NASDAQ: BLSI) announced that the Company has begun the process of patient enrollment in its Phase III trial of Altropane(R) 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.

Boston Life Sciences, Inc. (BLSI) is a development stage biotechnology company engaged in the research and development of novel therapeutic and diagnostic solutions for central nervous system diseases (CNS) and cancer. In addition to ALTROPANE, BLSI's products in development include: FLUORATEC(TM), a radioimaging agent for the diagnosis of PD and ADHD; Inosine and AF-1, nerve growth factors for the treatment of acute and chronic CNS disorders; Troponin I, a naturally-occurring anti-angiogenesis factor for the treatment of solid tumors; and novel therapies for the treatment of PD and ADHD.

Statements made in this press release other than statements of historical fact represent forward-looking statements. Such statements include, without limitation, statements regarding expectations or beliefs as to future results or events, such as the expected timing and results of clinical trials, discussions with regulatory agencies, schedules of IND, NDA and all other regulatory submissions, the timing of product introductions, the possible approval of products (including the ultimate approvability of ALTROPANE), and the market size and possible advantages of the Company's products. All such forward-looking statements involve substantial risks and uncertainties, and actual results may vary materially from these statements. Factors that may affect future results include: the availability and adequacy of financial resources, delays in the regulatory or development processes, results from clinical and pre-clinical trials, regulatory decisions (including the FDA's discretion following completion of this single, pivotal Phase III trial to require the Company to conduct additional clinical trials in order to achieve approvability of ALTROPANE), market acceptance of the Company's products, the ability to obtain intellectual property protection, the outcome of discussions with potential partners and other possible risks and uncertainties that have been noted in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K.