Boston Life Sciences Initiates Phase II Altropane-TM- Study in Diagnosis of Attention Deficit Hyperactivity Disorder -ADHD- in Children.Business Editors and Health/Medical Writers BOSTON--(BW HealthWire)--March 18, 2002 Goal of study is to differentiate children with 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 from those with anxiety disorders 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 its Phase II study to diagnose ADHD in children using Altropane, the Company's radio-imaging agent that targets the Dopamine Transporter (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. ), has been initiated. The 40 subject study will be performed at Children's Hospital of Philadelphia The Children's Hospital of Philadelphia is one of the largest and oldest children's hospitals in the world. "CHOP" has been ranked as the best children's hospital in the United States by U.S. News & World Report and Child Magazine in recent years. and University of Massachusetts Medical School UMMS is ranked fourth in primary care education among the nation’s 125 medical schools in the 2006 U.S.News & World Report annual guide, “America’s Best Graduate Schools”. UMMS is also a major center for research. in Worcester, Mass., two institutions of renowned excellence in the diagnosis and treatment of ADHD. Patient enrollment is anticipated to begin the first week of April, 2002. The study will enter children between ages 8-17 that have an expertly-determined psychiatric diagnosis of either ADHD (20 subjects) or one of three anxiety syndromes (Generalized Anxiety Disorder Generalized Anxiety Disorder Definition Generalized anxiety disorder is a condition characterized by "free floating" anxiety or apprehension not linked to a specific cause or situation. , Social Phobia, or Separation Anxiety Disorder “Separation Anxiety” redirects here. For the video game, see . Separation anxiety disorder is a psychological condition in which an individual has excessive anxiety regarding separation from home or from people to whom the individual has a strong emotional attachment [20 subjects]). An Altropane-SPECT scan will then be performed on each child and the indirect measure of DATs will be calculated by a nuclear medicine specialist without knowledge of the subject's previously established clinical diagnosis. The results of the ADHD group will then be statistically compared to those of the anxiety group. The working hypothesis is that children with ADHD will have a statistically-significant elevation in their calculated DATs compared to those with anxiety disorders. The degree of statistical separation of the groups will then be used in planning the Phase III study. "The successful results in our first Phase II study in adults, which demonstrated a highly-statistically significant elevation in DAT numbers in individuals with expertly-diagnosed ADHD as compared to normal volunteers, has led us to test Altropane in children," stated Dr. Marc Lanser, MD, Chief Scientific Officer of BLSI. "ADHD is often difficult to differentiate clinically from anxiety disorders in children; therefore any objective test to aid in differentiating these two groups could be of great practical importance," 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) 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 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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