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Boston Life Sciences Initiates In-house Production of Troponin With Further Improvements in Efficiency and Yield.


Business Editors and Health/Medical Writers

BOSTON--(BW HealthWire)--March 20, 2002

Production capacity able to meet all clinical trial needs;

Company requests Pre-IND meeting with 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.
 

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 had initiated regular production of its anti-angiogenic protein, Troponin I in its own facility in Baltimore, MD. The Company's manufacturing team is now able to produce all anticipated clinical trial material, using its internally developed proprietary manufacturing process. This in-house production should result in substantial cost and time savings. The Company is in the process of converting its GLP See gateway location protocol.  production facility to full GMP GMP (guanosine monophosphate): see guanine.  capability to meet FDA requirements for human-use material.

The Company also announced that it has submitted documentation and a request for a Pre-IND meeting with the FDA to discuss the Company's clinical development plans, and its proposed IND submission.

"We are pleased with the production process development progress that we have made in recent months, enabling us to control the production of Troponin ourselves" stated Marc E. Lanser, MD, and Chief Scientific Officer of BLSI. "This allows for very significant savings in production costs over the course of the clinical trials. We are now able to purify a "batch" of Troponin in 24 hours, compared to the four days required by our previous contract manufacturer. This increased efficiency has resulted in higher yield and even better biologic activity in the final product. We look forward to presenting our clinical development plans to the FDA," 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(TM) and FLUORATEC(TM) radioimaging agents for the diagnosis of PD 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 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 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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Publication:Business Wire
Date:Mar 20, 2002
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