Posiphen(TM) to be evaluated in Phase I study for Alzheimer's Disease
Aug 1, 2005 - 11:45:00 PM
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"The initiation of the Posiphen Phase I program is an important milestone. Alzheimer's disease devastates millions of individuals worldwide and we remain committed to advancing this potential treatment option that may slow or halt the progression of the disease."
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By Axonyx, Inc.,
[RxPG] Axonyx, Inc. (NASDAQ: AXYX) a U.S.-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application, submitted in June 2005, allowing Phase I clinical testing of Posiphen(TM). The first Phase I clinical study is expected to begin shortly and will primarily evaluate the safety of Posiphen in healthy volunteers. Posiphen is in development by the Company for the potential treatment of Alzheimer's Disease progression.
"The initiation of the Posiphen Phase I program is an important milestone," stated Gosse B Bruinsma, MD, President and CEO of Axonyx Inc. "Alzheimer's disease devastates millions of individuals worldwide and we remain committed to advancing this potential treatment option that may slow or halt the progression of the disease."
In preclinical studies, Posiphen has been shown to lower beta amyloid precursor protein ((beta)APP) and beta amyloid (A(beta)) levels in rodents as well as demonstrating a favorable side-effect rate. The presence of toxic beta-amyloid in the brains of Alzheimer's disease (AD) patients is considered by many experts to be a key pathological event in the causation as well as the progression of AD.
Dr. Bruinsma continued, "In addition to the start of the Posiphen Phase I clinical study, we look forward to the submission of an IND application for BisNorCymserine (BNC), our butyrylcholinesterase inhibitor for the potential treatment of the symptoms of memory and cognition loss in severe AD. We also continue to evaluate additional opportunities to further expand our pipeline of CNS compounds."
About Posiphen(TM)
Posiphen(TM) is the positive isomer of Phenserine in development for the treatment of mild to moderate Alzheimer's Disease. Posiphen's mechanism of action has been shown to result in a dose dependent reduction of A(beta), which may potentially result in slowing AD progression. Axonyx has world-wide patent rights to Posiphen(TM) with NIH/NIA.
Publication:
United States Food and Drug Administration
On the web:
www.axonyx.com 
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Additional information about the news article
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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. 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 AD, Posiphen(TM) - a potential disease progression treatment for AD and BisNorCymcerine (BNC) - a potential symptomatic treatment of severe AD.
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. Axonyx cannot assure that the Phase I and/or other Phases of clinical trial program, amendments thereto or others, if any, with Posiphen will prove successful, that the safety and efficacy profile of Posiphen exhibited in the preclinical program to date will remain the same, be better or worse in future preclinical or clinical trials, if any, that the preclinical results related to the regulation of beta-APP will be substantiated by any future Posiphen clinical trials and that Posiphen will be able to slow the progression of Alzheimer's disease, that the future clinical trial data will differentiate Posiphen from the currently or future marketed drugs, that any efficacy and safety results of a Phase III trial program, if pursued, will prove pivotal, that Axonyx will obtain the necessary financing to complete the Posiphen or other development programs, that the Company's development work on Posiphen will support an NDA filing, that the results of Phase III trials will allow Posiphen to be approved by the FDA, that the FDA will grant marketing approval for Posiphen, that if Posiphen 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 successful development of or acceleration of the development of and optimize marketing opportunities for, Posiphen. Axonyx cannot assure that it will be able to advance any of its other compounds in development towards IND status or beyond. 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.
Contacts
Axonyx Inc.
Colin Neill, 212-645-7704
www.axonyx.com
or
Media Contact:
GCI Group
Dawn Lauer, 212-537-8088
[email protected]
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