Axonyx (NASDAQ:AXYX)
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Axonyx Inc. (NASDAQ: 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 of
Axonyx Inc. at the Rodman and Renshaw 7th Annual Healthcare Conference
at the New York Palace Hotel, New York, NY. The Axonyx presentation is
scheduled for 8:40 a.m. Eastern Time on Tuesday, November 8, 2005 and
will be web cast live on the company's website.
CLINICAL DEVELOPMENT PROGRAM STATUS
Phenserine
Axonyx has now evaluated its entire Phenserine development
program, including the results from the first Phase III 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 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, 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) 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) 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 and its primary mechanism of action
results in a dose dependent reduction of Acetylcholine. 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 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. 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
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. 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 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.