Boston Life Sciences Signs Contract for Clinical Trial GMP Supplies of Its Anti-Cancer Agent Troponin.Business Editors/Health and Medical Writers BIOWIRE2K BOSTON--(BW HealthWire)--Jan. 30, 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) announced that it has signed a supply agreement with Marathon Biopharmaceuticals under which Marathon will manufacture GMP GMP (guanosine monophosphate): see guanine. Troponin I for BLSI's Investigational New Drug (IND) application and its Phase I/II clinical trials expected to commence later this year. BLSI will also use the anti-angiogenic material to complete its pre-clinical program. "We are very pleased to secure this supply agreement with Marathon Biopharmaceuticals," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. "During the past two years, we have been working diligently to refine the manufacturing process for 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. , and can now consistently manufacture material with high levels of anti-angiogenic activity and purity. Our collaboration with Marathon will enable us to manufacture Troponin in the GMP environment mandated by 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. . We anticipate initiating our Phase I/II clinical trial in high-risk cancer patients in the second half of 2001," added Dr. Lanser. Boston Life Sciences' Troponin I is an extremely potent, naturally-occurring protein that inhibits and suppresses angiogenesis (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 was shown to inhibit experimental metastatic tumor growth when administered at 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 Children's Hospital Boston is a children's hospital located in the Longwood Medical and Academic Area of Boston, Massachusetts. Located at 300 Longwood Avenue, Children's is adjacent both to its teaching affiliate, Harvard Medical School, and to Dana-Farber Cancer Institute. ) for the post-surgery prevention of metastases in cancer patients. "Our program in naturally-occurring anti-angiogenic proteins is one of the earliest product-specific efforts to emerge out of Children's Hospital Boston where the vital link between blood vessel development and cancer was originally so well demonstrated," continued Dr. Lanser. "We are delighted to reach the stage of development where the highly promising anti-angiogenic potential of Troponin can be tested in patients," added Dr. Lanser. "We are equally pleased to add Boston Life Sciences to our growing roster of companies seeking a cGMP qualified manufacturing facility for their products," stated Anthony J. Rotunno, VP and General Manager of Marathon Biopharmaceuticals. "Our state-of-the-art 65,000 square foot manufacturing plant has received full GMP certification from the FDA. We presently manufacture commercial quantities of an FDA approved drug for one biotechnology company and are producing clinical grade material for a dozen other companies. We have the necessary facilities and the proven expertise to assist Boston Life Sciences in the GMP production of Troponin." 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 Fluorotec, 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. Marathon Biopharmaceuticals is an operating division of CoPharma, Inc., a private biotechnology company based in Hopkinton, MA. Marathon's facility systems include microbial cell expression systems from 10L up to 800L, protein purification suites with microfiltration and ultrafiltration ultrafiltration /ul·tra·fil·tra·tion/ (ul?trah-fil-tra´shun) filtration through a filter capable of removing very minute (ultramicroscopic) particles. ul·tra·fil·tra·tion n. systems, centrifugation and chromatography, fully equipped and staffed QC laboratories, and fully equipped process development and product characterization laboratories. Marathon is the current commercial supplier of one FDA approved product and produces clinical material for over a dozen other biotechnology and pharmaceutical companies. 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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