Boston Life Sciences Plans Filing of Special Protocol Assessment for Additional Phase III Study For ALTROPANE.Business Editors/Health/Medical Writers BOSTON--(BUSINESS WIRE)--June 16, 2003 Submission of NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any would likely occur after additional Phase III study is completed Boston Life Sciences, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BLSI BLSI Boston Life Sciences, Inc. ) announced that it will pursue a Special Protocol Assessment (SPA) filing with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for the Company's radioimaging agent, ALTROPANE(R). The Company intends to file the SPA shortly in connection with BLSI's plans to conduct an additional Phase III clinical study in Essential Tremor Essential tremor An uncontrollable (involuntary) shaking of the hands, head, and face. Also called familial tremor because it is sometimes inherited, it can begin in the teens or in middle age. The exact cause is not known. patients prior to NDA submission, as recommended by the FDA in recent discussions with the Company. According to recent FDA-published guidance, an SPA filing provides for a 45-day review of a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the protocol. This review forms the basis of an agreement with the Agency regarding the steps to be taken to achieve ultimate approvability of a company's NDA filing. Dr. Robert J. Rosenthal, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and President, stated, "We believe that the filing of an SPA and the conduct of an additional Phase III trial, designed in coordination with the FDA, is in accord with the Agency's input and is therefore prudent and, will place us in a stronger position to secure approval. This trial will be designed to specifically distinguish Benign Essential Tremor (BET) from Parkinsonian tremors, which is an important clinical problem. We recognize that our strategy will delay the filing of the NDA, which we previously indicated would occur by the end of the first half of 2003. However, we have concluded that this course of action represents the best long term strategy to fully maximize the market potential for ALTROPANE(R) and is, consequently, in the best interests of movement disorder patients and our shareholders." 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 See Continuous net settlement. CNS See continuous net settlement (CNS). ) and cancer. BLSI's products in development include: ALTROPANE(R) and FLUORATEC(TM) radioimaging agents for the diagnosis of PD and ADHD Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or ; AF-1 and Inosine inosine /in·o·sine/ (I) (in´o-sen) a purine nucleoside containing the base hypoxanthine and the sugar ribose, which occurs in transfer RNAs and as an intermediate in the degradation of purines and purine nucleosides to uric acid and in , 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 operating results and financial position, 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, 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, the level of operating expenses incurred, the ability to obtain intellectual property protection, delays in the regulatory or development processes, results of scientific data from clinical trials, the outcome of discussions with potential partners, regulatory decisions, market acceptance of the Company's products, 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. |
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