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Boston Life Sciences Announces Successful Toxicology Test of Its Anti-Angiogenic Agent, Troponin; Continuous Infusion of Troponin in Primates Yields No Evidence of Toxicity.


Business Editors and Health/Medical Writers

BOSTON--(BW HealthWire)--Nov. 1, 2001

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 the Company has completed the required pre-IND one-month toxicology tests of its anti-angiogenic protein, Troponin I. Preliminary results revealed no significant toxicity in either species (primates and rats) during or after the one-month infusion period. The results of these tests form an important part of the Company's Investigational New Drug (IND) application which is necessary for the initiation of human clinical trials. The Company is developing 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.
 for the prevention and treatment of metastases from solid tumors in patients who are at high risk for such metastatic recurrence.

These tests evaluated the toxic potential of recombinant human Troponin when administered as a continuous infusion for a one-month period in both rats and primates. These studies incorporated doses up to ten times the anticipated dose to be used in human clinical trials. Significantly, primates exhibited no demonstrable immune response. Preliminary evaluation revealed no adverse effects on any organs, and blood tests revealed no significant abnormalities in hematologic hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 or chemistry parameters. As totally expected, wound healing, which relies heavily on angiogenesis, was clearly delayed in most animals receiving Troponin. This constitutes further evidence that Troponin has anti-angiogenic effects when administered in this manner.

"The results from these studies demonstrate that Troponin can be administered by continuous infusion at high doses in primates without obvious toxicity," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. "We are very heartened by the successful completion of these studies. These data plus the previously-announced completion of our GMP GMP (guanosine monophosphate): see guanine.  manufacturing of Troponin, keeps us on track for the filing of our IND and our goal of initiation of human clinical trials early next year," added Dr. Lanser.

Troponin I was the first endogenous (naturally-occurring) anti-angiogenic protein identified by scientists at Children's Hospital in Boston. Troponin potently inhibits the response of blood vessel cells to the major tumor-derived pro-angiogenic factors VEGF VEGF vascular endothelial growth factor.  and FGF, thereby preventing the establishment of the vascular supply to solid tumors. Since the growth and spread of micrometastases is the major cause of cancer recurrence following surgical removal of primary tumors, Troponin has the potential to prevent the growth of these metastases in patients who are at "high risk" of a relapse following the removal of their primary tumor. The Company hopes to reduce the recurrence rate in these high-risk patients by administering Troponin via a subcutaneously-implanted pump in the clinical trials scheduled for next year.

BLSI is developing novel diagnostics and therapeutics for Parkinson's Syndrome (PS) 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(TM) and Fluorotec(TM), radioimaging agents for the diagnosis of PS and ADHD; Troponin I, 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 PS 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 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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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:Nov 1, 2001
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