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Boston Life Sciences Successfully Scales-Up GMP Manufacturing of It's Anti-Angiogenic Protein for Use in Humans.


Business Editors and Health/Medical Writers

BIOWIRE2K

BOSTON--(BW HealthWire)--June 18, 2001

Proprietary Production Methodology for Troponin I Yields Active

Protein Suitable for IND Submission and Human Trials

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) announced that the Company has completed development of its proprietary GMP GMP (guanosine monophosphate): see guanine.  manufacturing process for Troponin I, and has produced large-scale quantities of material necessary for the filing of an Investigational New Drug (IND) application with the 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.
. The proprietary GMP manufacturing methodology was developed internally by BLSI's protein manufacturing team and utilized by Marathon Biopharmaceuticals of Hopkinton, MA under contract with BLSI. The Company believes that the newly-completed production scale will allow for the supply of adequate amounts of protein for the Phase I/II clinical cancer trials, scheduled for later this year. Additionally, this manufacturing process may be licensed by BLSI to other companies who have difficulty producing their complex therapeutic protein.

Troponin I is an extremely potent naturally-occurring protein that inhibits angiogenesis (the primary blood vessel formation), a requisite for both primary and metastatic tumor growth. In studies previously published in the Proceedings of the National Academy of Sciences The Proceedings of the National Academy of Sciences of the United States of America, usually referred to as PNAS, is the official journal of the United States National Academy of Sciences.  (PNAS), Troponin troponin /tro·po·nin/ (tro´po-nin) a complex of muscle proteins which, when combined with Ca2+, influence tropomyosin to initiate contraction.

tro·po·nin
n.
 was shown to significantly inhibit experimental metastatic tumor growth when administered at only a small percentage (2-4%) of the dose required for other leading anti-angiogenic agents. BLSI has been developing Troponin I (originally licensed from Children's Hospital, Boston) for the post-surgery prevention of metastases in cancer patients.

"We are extremely pleased to have achieved this crucial milestone in the development of Troponin," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. "As an inhibitor of both VEGF VEGF vascular endothelial growth factor.  and FGF (blood vessel growth factors), we believe that this metastatic cancer therapeutic agent is truly unique in its potent anti-angiogenic properties. Further, we believe it offers relatively good production efficiency, consistently excellent biologic activity, high solubility, and chemical stability. These features appear to make Troponin almost an ideal anti-angiogenic product, and one that appears to meet (thus far) the criteria for a successful commercial product. Our manufacturing goal was to be able to efficiently produce large amounts of active protein suitable for administration in small doses by constant infusion. Constant infusion is presently considered to be the optimal means of delivering anti-angiogenic compounds. We believe that we have now succeeded in meeting these criteria, and hope to demonstrate Troponin's safety and efficacy in high-risk cancer patients as quickly as possible," added Dr. Lanser.

BLSI is developing novel diagnostics and therapeutics for Parkinson's Disease (PD) and Attention Deficit Hyperactivity Disorder attention deficit hyperactivity disorder (ADHD), formerly called hyperkinesis or minimal brain dysfunction, a chronic, neurologically based syndrome characterized by any or all of three types of behavior: hyperactivity, distractibility, and impulsivity.  (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
) as well as treatments for cancer, autoimmune disease, and central nervous system disorders Nervous system disorders

A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency
. BLSI's products in development include: Altropane and Fluoratec, radioimaging agents for the diagnosis of PD and ADHD; Troponin, a naturally-occurring anti-angiogenesis factor for the treatment of solid tumors; 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 See Continuous net settlement.

CNS

See continuous net settlement (CNS).
 disorders; novel therapies for the treatment of PD and ADHD; and transcription factors that may control the expression of molecules associated with autoimmune disease and allergies.

Statements made in this press release other than statements of historical fact may 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 (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  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 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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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jun 18, 2001
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