Axonyx Provides Update on Clinical Development Program and Strategic Initiatives.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Axonyx 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 : AXYX) announced today the following updates to its clinical development program and strategic initiatives. These will be reviewed by Gosse Bruinsma, MD, 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 Axonyx Inc. at the Rodman and Renshaw 7th Annual Healthcare Conference at the New York Palace
CLINICAL DEVELOPMENT PROGRAM STATUS Phenserine Axonyx has now evaluated its entire Phenserine development program, including the results from the first Phase III Noun 1. phase III - 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 FDA trial announced in February and March 2005, the result of the curtailed and combined analysis of the second and third Phase III trials that was reported in September 2005 and the interim analyses of the beta amyloid amyloid /am·y·loid/ (am´i-loid) 1. starchlike; amylaceous. 2. the pathologic, extracellular, waxy, amorphous substance deposited in amyloidosis, being composed of fibrils in bundles or in a meshwork of polypeptide trial announced in March and July 2005 as well as recent additional patient data. The Company has determined that it will not commit further resources to the development of Phenserine. As previously reported, none of the trials achieved statistical significance for the primary end points, however, positive signals were observed in all the Phenserine clinical trials to date, including the interim analyses of the Phase IIb beta amyloid trial. The results of this trial to date appear to show a difference between Phenserine 15mg and placebo on the levels of beta amyloid 1-42 (A beta 1-42). The magnitude of this difference and the variability of these data show that a larger investigation than planned would be needed to demonstrate a statistically significant effect. The Company believes that a re-formulated Phenserine to achieve potentially higher drug exposure to the patient may improve the efficacy profile and potential amyloid lowering effects. The clinical trials to date on Phenserine, including extensive preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. , have provided the Company with a comprehensive set of data. The Company plans on utilizing this data set in a marketing package for potential licensees. Axonyx' goal is to identify a partner that is able and willing to commit the necessary financial resources to the compound's further development. Axonyx will not incur any additional development expenses for Phenserine beyond those expenses needed to close the ongoing activities in an orderly fashion. Posiphen(TM) Posiphen has been shown to lower beta-amyloid precursor protein (beta -APP) levels in pre-clinical studies. The primary mechanism of action results in a dose dependent reduction of beta amyloid, which may result in slowing AD progression. The initial pre-clinical side effect rates potentially allow for higher clinical doses. On August 1, 2005 the Company announced that the US Food and Drug Administration (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. ) has approved its investigational new drug (IND) application allowing Phase I clinical testing of Posiphen. The first Phase I clinical study commenced in August 2005 and will primarily evaluate the safety of Posiphen in healthy volunteers. BisNorCymserine BisNorCymserine (BNC (hardware) BNC - A connector for coaxial cable such as that used for some video connections and RG58 "cheapernet" connections. A BNC connector has a bayonet-type shell with two small knobs on the female connector which lock into spiral slots in the male connector when it is twisted ) is a highly selective butyrylcholinesterase inhibitor. Butyrylcholinesterase is found in high concentration in the plaques taken from individuals who have died from AD. Butyrylcholinesterase appears to have an increasing role with advancing 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. and its primary mechanism of action results in a dose dependent reduction of Acetylcholine acetylcholine (əsēt'əlkō`lēn), a small organic molecule liberated at nerve endings as a neurotransmitter. It is particularly important in the stimulation of muscle tissue. . The initial pre-clinical side effect rate potentially allows higher clinical doses. A secondary mechanism of action is associated with dose dependent reductions of beta-APP and A beta. BNC, the lead compound from our butyrylcholinesterase family, is currently in full pre-IND development. Axonyx plans an IND submission in the first quarter of 2006 followed by the initiation of Phase I clinical studies in first quarter 2006. STRATEGIC INITIATIVES The Company intends to use its financial resources, previously allocated to the Phenserine program, to expand its pipeline. Current activities include screening and evaluation of companies, potential compounds and products to determine their strengths and commercial potential in addition to their strategic fit with the Company and its therapeutic focus. Axonyx is primarily targeting opportunities in the CNS See Continuous net settlement. CNS See continuous net settlement (CNS). area, but other therapeutic areas may also be considered. About Axonyx Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds for the treatment of 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 . The Company currently has three compounds in development for Alzheimer's disease, namely Phenserine - a potential symptomatic and disease progression treatment of mild to moderate Alzheimer's disease (AD), Posiphen(TM) - a potential disease progression treatment for AD now in Phase I, and BisNorCymserine (BNC) - a potential symptomatic treatment Symptomatic treatment is any medical therapy of a disease that only affects its symptoms, not its cause, i.e., its etiology. It is usually aimed at reducing the signs and symptoms for the comfort and well-being of the patient, but it also may be useful in reducing organic of severe AD now in pre-Investigational New Drug (IND) stage. 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. . Specifically, with respect to our drug candidates Phenserine, Posiphen(TM) and BisNorCymserine, Axonyx cannot assure that: any preclinical studies or clinical trials, whether ongoing or conducted in the future, will prove successful, and if successful, that the results can be replicated; safety and efficacy profiles of any of its drug candidates will be established, or if established, will remain the same, be better or worse in future clinical trials, if any; pre-clinical results related to cognition and the regulation of beta-APP will be substantiated by ongoing or future clinical trials, if any, or that any of its drug candidates will be able to improve the signs or symptoms of their respective clinical indication or slow the progression of Alzheimer's disease; any of its drug candidates 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, will be approved by the FDA or its equivalent, or if approved, will prove competitive in the market; Axonyx will be able to successfully out-license any of its drug candidates; Axonyx will be able to successfully in-license any additional compounds; or that Axonyx will have or obtain the necessary financing to support its drug development programs. 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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