Boston Life Sciences Announces Expansion of Clinical, Regulatory and Patent Departments.Business Editors and Health/Medical Writers BOSTON--(BUSINESS WIRE)--Nov. 20, 2001 Clinical Directors in Neuroimaging, CNS See Continuous net settlement. CNS See continuous net settlement (CNS). Therapeutics and Cancer, as well as Directors of Regulatory and Patent Affairs added to meet needs of clinical development programs 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 recently hired three new Clinical Directors specializing in the Company's clinical development areas as well as a Director of Regulatory Affairs to lead the Company's regulatory filing processes in each of these areas. In addition, the growing patent portfolio derived from the ongoing collaborations with Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. and its affiliated hospitals is now being managed by in-house Patent Counsel. The Company has also hired clinical associates in each of these areas to assist the Directors in planning and managing the upcoming clinical trials. In Neuro-imaging Diagnostics, the Company has hired Dr. Robert Licho, presently an Assistant Professor of Nuclear Medicine, University of Massachusetts The system includes UMass Amherst, UMass Boston, UMass Dartmouth (affiliated with Cape Cod Community College), UMass Lowell, and the UMass Medical School. It also has an online school called UMassOnline. Medical Center. Dr. Licho is an expert in SPECT imaging and was a Principal Investigator in the Company's Altropane Parkinson's Disease 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 clinical trials. Dr. Licho is directing the Company's Altropane Phase II clinical trials in both children and adults for the diagnosis of ADHD. In CNS Therapeutics, the Company has hired Dr. Marie-Louise Jacques to direct the Company's clinical efforts using 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 for the regenerative treatment for stroke and spinal cord injury Spinal Cord Injury Definition Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control. Description Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States. , and the clinical development of the Company's Dopamine Transport (DAT (1) (Dynamic Address Translator) A hardware circuit that converts a virtual memory address into a real address. See also DAT file. (2) (Digital Audio Tape) A magnetic tape technology used for backing up data. ) blockers to treat Parkinson's Disease and ADHD. Dr. Jacques was previously Head of International Clinical R&D (ex-US) at Novartis' ophthalmic division. In Oncology, the Company has hired Dr. Lee Schacter, to direct the Company's anti-angiogenic program in oncology. Dr. Schacter is charged with designing and implementing the Phase I/II clinical study of Troponin as a preventative treatment for cancer metastases in high risk patients. Dr. Schacter was previously Senior Medical Director/Global Product Team Physician at Astra Zeneca and prior to that was Director, Clinical Cancer Research at Bristol Meyers Squibb. The Company has hired Jeanne-Marie Varga as Director, Regulatory Affairs. Ms. Varga was previously Director, Regulatory Affairs at Baxter Healthcare Corp. and V.P. of Worldwide Regulatory affairs at Sanofi Diagnostics Pasteur, Inc. Prior to these Regulatory Affairs positions, Ms. Varga was a Senior Scientific Reviewer, Immunology Branch at 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. . Ms. Varga is in charge of compiling and filing the Company's New Drug Application (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 ) for Altropane for the diagnosis of Parkinson's Disease, as well as all subsequent regulatory filings for the Company's products. Dr. Leslie Levine has been hired as Director, Intellectual Property and Patent Affairs. Dr. Levine is a graduate of Harvard Law School Harvard Law School (colloquially, Harvard Law or HLS) is one of the professional graduate schools of Harvard University. Located in Cambridge, Massachusetts, Harvard Law is considered one of the most prestigious law schools in the United States. and earned a PhD in Physiology from the University of Pennsylvania School of Medicine The University of Pennsylvania's School of Medicine, presently located in the University City section of Philadelphia, Pennsylvania, was the United States's first school of medicine, founded at the College of Philadelphia, as the University was then called. . Dr. Levine was previously Assistant General Counsel at Biogen, Inc. and Director of Intellectual Property at Transkaryotic Therapies, Inc. In addition to the Directors, the Company has expanded its team of Clinical Research Associates to assist the Directors in managing and implementing the individual clinical trials for each product in clinical development. David Hillson, President and 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. of BSLI commented: "The maturation and transition of BLSI from a pre-clinical product development company to a company fully engaged in human clinical trials is reflected in these major additions to our professional staff. We have five human clinical trials on-deck for 2002, spread over phase I, II and III, as well as an NDA to be filed. The scientific basis for all this progress is detailed in numerous scientific publications produced by our collaborating scientists. It is the quality of this work that has enabled us to attract such a high-caliber team." 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) 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, nerve growth factors for the treatment of acute and chronic 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 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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