Axonyx Shareholder Meeting Elects Directors and Discusses Status of Phenserine Clinical Trials.Business Editors NEW YORK--(BUSINESS WIRE)--July 10, 2003 AXONYX INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (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 : AXYX) held its Annual Meeting of Stockholders recently and elected the following nominees as directors of the Company - Gosse B. Bruinsma, M.D., Louis G. Cornacchia, Michael R. Espey, Steven H. Ferris, Ph.D., Marvin S. Hausman, M.D., Gerard J. Vlak, Ph.D. At a Board of Directors meeting following the Annual Meeting of Stockholders, the newly elected directors re-appointed the current officers and elected Marvin S. Hausman as Chairman of the Board of Directors. Present officers are: Marvin S. Hausman, M.D., President, 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. and Chairman, Gosse B. Bruinsma, M.D., Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. , Treasurer, President Axonyx Europe, Michael R. Espey, Vice President and Secretary. Management presented an update on the current status of the Phenserine clinical trials with shareholders and noted the following: 1) Recruitment of patients for each trial, the Phase IIB IIB Institute for Independent Business IIB Institute of International Business IIB Institute of International Bankers IIB International Investment Bank IIB Indian Institute of Banking & Finance IIB Included in Bankruptcy IIB Ice, Ice, Baby and the Phase III, is ongoing. 2) Data from the Phase IIB clinical trial is currently expected to be available in the first quarter of 2004. 3) Data from the Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the is currently expected to be available near the end of 2004. Phenserine is currently undergoing clinical testing in a Phase IIB study designed to evaluate Phenserine's ability to lower the levels of the beta-amyloid precursor protein and beta-amyloid in the plasma and cerebrospinal fluid cerebrospinal fluid (CSF) Clear, colourless liquid that surrounds the brain and spinal cord and fills the spaces in them. It helps support the brain, acts as a lubricant, maintains pressure in the skull, and cushions shocks. of mild to moderate Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. (AD) patients. The presence of toxic beta-amyloid in the brains of AD patients is considered by many experts to be a key pathological event in the causation as well as the progression of AD. Dr. Gosse B. Bruinsma, COO, stated, "We are very excited that our clinical trials have begun and currently anticipate that the Phase IIB and Phase III trials will be completed within the timeframe indicated above. In our judgment, Phenserine is an "approvable" drug based on a number of factors; one, it is an acetylcholinesterase-Inhibitor-a drug class that is known to improve the symptoms of Alzheimer's, two, Phase II data have shown that the drug has positive efficacy and low rate of adverse events (AE) and, three, significantly, Phenserine has shown in preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. to have the unique feature of inhibiting the beta-Amyloid precursor." About Axonyx Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds and new technologies useful in the diagnosis and treatment of Alzheimer's disease, human memory disorders and prion-based illnesses such as Mad Cow Disease mad cow disease: see prion. mad cow disease or bovine spongiform encephalopathy (BSE) Fatal neurodegenerative disease of cattle. Symptoms include behavioral changes (e.g. . This press release may contain forward-looking statements or predictions. These statements represent our judgment to date, and are subject to risks and uncertainties that could materially affect the Company including those risks and uncertainties described in the documents Axonyx files from time to time with the SEC, specifically Axonyx's annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. . Axonyx cannot assure that the recruitment of patients for the Phase IIB and/or the Phase III clinical trial will not experience unexpected delays, that the timeline for completion of the clinical trials will not be delayed by recruitment problems, if any, or delays due to other factors, that the Phase IIB and/or Phase III clinical trials , or others, if any, with Phenserine will prove successful, that the safety and efficacy profile of Phenserine exhibited in the previous small Phase II trial will remain the same in the Phase IIB and Phase III clinical trials, or future clinical trials, if any, that the preclinical results related to the regulation of beta-APP will be substantiated by the Phenserine Phase IIB clinical trial and that Phenserine will be able to slow the progression of Alzheimer's disease, that the Phase IIB clinical trial data will differentiate Phenserine from the currently marketed drugs, that the efficacy results of the Phase III trial will prove pivotal, that the efficacy data from the Phase IIB clinical trial will be able to be used in the Phase III trial efficacy data, that Axonyx will obtain the necessary financing to complete the Phase III Phenserine trials, that the Company's development work on Phenserine will support an 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 filing, that the results of the Phase III trials will allow Phenserine to be approved 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. , that the FDA will grant marketing approval for Phenserine, that if Phenserine is approved by the FDA, it will prove competitive in the market, and that Axonyx will obtain licensing or corporate partnership agreements that will enable acceleration of the development of and optimize marketing opportunities for, Phenserine, or that Axonyx will be able to advance any other potential memory enhancing compound toward IND status. Axonyx undertakes no obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. |
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