Axonyx Inc.
AXONYX Inc. english
AXONYX INITIATES BETA-AMYLOID CLINICAL TRIAL WITH PHENSERINE FOR ALZHEIMERS DIS
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AXONYX INITIATES BETA AMYLOID CLINICAL TRIAL WITH PHENSERINE FOR ALZHEIMERS
DISEASE
NEW YORK, June 2, 2003 Axonyx Inc. (NASDAQ: AXYX) today announced the
initiation of the first trial in its planned Phase IIb Phase III clinical
program for Phenserine. Regulatory and Local Ethical Committee approvals in the
U.K. have been received and patients will now be recruited into the Companys
beta amyloid Phase IIb clinical trial. This randomized placebo controlled
double blind trial will evaluate Phenserines ability to lower the levels of the
beta amyloid precursor protein (beta APP) and beta amyloid in the plasma and
cerebrospinal fluid of mild to moderate Alzheimers disease (AD) patients.
Patients in this trial will also undergo testing with the standard memory and
cognition tests, the ADAS cog and CIBIC plus efficacy endpoints, recommended by
the United States FDA and European regulatory authorities. Phenserine is an
acetylcholinesterase and beta APP inhibitor that has previously been shown to be
safe and efficacious in improving memory in a 12 week study in mild to moderate
AD patients.
The objective of this clinical trial is to substantiate previously published in
vitro and in vivo preclinical data that has consistently shown that Phenserine
can reduce the levels of beta APP and beta amyloid. The presence of toxic beta
amyloid in the brains of Alzheimers disease patients is considered by many
experts to be a key pathologic event in the causation as well as the progression
of AD.
The data from this trial has the potential to differentiate Phenserine from
other approved and marketed AD drugs in its class, which currently generate
revenues in excess of dollar 1.5 billion worldwide, stated Gosse B. Bruinsma,
M.D., Chief Operating Officer of Axonyx.
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 Alzheimers disease, human memory
disorders and prion based illnesses such as Mad Cow Disease.
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 IIb clinical trial, 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
clinical trial, 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 Axonyx will
obtain the necessary financing to complete any Phase III Phenserine trials, that
the efficacy data from the Phase IIb clinical trial will be able to be used
with any Phase III efficacy data, that the FDA will approve the protocol for a
Phase III trial, that the Companys development work on Phenserine will support
an NDA filing, that the results of the Phase III trials will allow Phenserine to
be approved by the FDA, 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.
contact:
Investor relation Europe:
Baltic Investment Consulting GmbH
koenigstrasse 58
23552 luebeck
tel: +49 451 400 7177
fax: +49 451 400 7118
end of message, (c)DGAP 03.06.2003
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WKN: 928329; ISIN: US05461R1014; Index:
Listed: Freiverkehr in Frankfurt und Berlin-Bremen;
031738 Jun 03
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