Boston Life Sciences Announces Completion of Phase III Altropane Trial Enrollment.Business/Technology Editors and Health/Medical Writers BIOWIRE2K BOSTON--(BW HealthWire)--March 15, 2000 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 enrollment in the Company's Phase III trial for the use of Altropane to diagnose early Parkinson's Disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. (PD) has been completed. Approximately 160 patients were enrolled in 20 sites throughout the U.S. "We are pleased to have completed this milestone in the development of Altropane to diagnose early PD. Completion of the trial and analysis of the data will take place during the second quarter of this year, during which time we will be working on our cGMP manufacturing capacity. We are looking forward to filing for marketing approval later this year," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. "There is currently no objective test for PD. Clinical diagnosis of early PD can be problematic, since studies have reported that as much as 25-30% of early cases may be misdiagnosed. The most common condition that can be misdiagnosed as PD is Benign Essential Tremor Essential tremor An uncontrollable (involuntary) shaking of the hands, head, and face. Also called familial tremor because it is sometimes inherited, it can begin in the teens or in middle age. The exact cause is not known. , a condition which does not require treatment and which does not respond to conventional PD therapy. We believe that the use of Altropane in early PD will focus on increasing the accuracy and timeliness of the diagnosis and thus facilitate earlier and more appropriate treatment. This is especially true in younger individuals, in whom the diagnosis of PD is ordinarily not readily considered," added Dr. Lanser. There are approximately 250,000 individuals per year in the U.S. who see a physician because of the onset of a movement disorder. Of these, 50,000 patients per year are diagnosed with PD. The Company believes that the market for Altropane for this indication could be $50-$75 million per year. In addition to the PD indication, BLSI is developing Altropane for the diagnosis of 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 ). The Company plans to initiate a Phase II trial for the ADHD indication in the second quarter of this year. BLSI is developing novel diagnostics and therapeutics for Parkinson's Disease and Attention Deficit Hyperactivity Disorder (ADHD) as well as treatments for cancer, autoimmune disease autoimmune disease, any of a number of abnormal conditions caused when the body produces antibodies to its own substances. In rheumatoid arthritis, a group of antibody molecules called collectively RF, or rheumatoid factor, is complexed to the individual's own gamma , 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, a radioimaging agent for the diagnosis of Parkinson's Disease 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; fusion toxins for the treatment of cancer and multiple sclerosis; novel therapies for the treatment of Parkinson's Disease 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/A. |
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