From rxpgnews.com
Posiphen(TM) to be evaluated in Phase I study for Alzheimer's Disease
By Axonyx, Inc.,
Aug 1, 2005 - 11:44:38 PM
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.
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