TorreyPines Therapeutics, Inc. today
announced completion of its second Phase I study with NGX267 in clinical
development for the treatment of Alzheimer's disease. This study evaluated
the safety of NGX267 in healthy elderly volunteers. In a previous Phase I
study, NGX267, administered as single doses, was shown to be well-tolerated
in healthy, younger adult males. NGX267, a selective cholinergic
muscarinic, or M1, receptor agonist, has demonstrated potential in
providing both symptomatic improvement and disease modification in animal
models of Alzheimer's disease.
This second Phase I study was a double-blind, placebo-controlled,
single ascending dose study that evaluated the safety, tolerability and
pharmacokinetics of NGX267 in healthy males and females between the ages of
65 and 80, reflecting the age of the primary Alzheimer's disease
population. The trial enrolled 26 volunteers at one center in the U.S.
Clinical data showed that NGX267 was well tolerated at single doses up to
and including 15 mg and that evidence of cholinergic activation was
detected at these doses. Additionally, exposure levels of NGX267 in elderly
men and women at doses of 15 mg or lower may be comparable to those levels
tested in a transgenic mouse study, published in the journal Neuron (Vol
49, 671-682) in March of this year. In that animal study, NGX267 improved
behavioral symptoms and lowered brain AB42, a toxic peptide that is the
major component of amyloid plaques. These plaques are considered a primary
histopathological hallmark of Alzheimer's disease.
"These favorable safety data in a population at highest risk of
developing Alzheimer's disease support development of NGX267 as a potential
therapy for Alzheimer's disease," said Neil Kurtz, M.D., President and
Chief Executive Officer of TorreyPines. "This compound may potentially
provide patients and caregivers with a meaningful advance in the treatment
of this disease by addressing both the symptoms and the progression of
Alzheimer's disease."
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a biopharmaceutical company that
discovers and develops small molecule drugs to treat diseases and disorders
of the central nervous system. Led by an accomplished management team,
TorreyPines is leveraging novel drug targets and technologies to deliver
new therapies for migraine, chronic pain, including neuropathic pain, and
Alzheimer's disease. Its therapies are intended to offer advantages over
current therapies. On June 8, 2006, TorreyPines announced that it had
entered into a definitive merger agreement with Axonyx Inc. (Nasdaq: AXYX).
The resulting company will be named TorreyPines Therapeutics, Inc. and be
headquartered in San Diego. Further information is available at
torreypinestherapeutics.
Additional Information about the Merger and Where to Find It
In connection with the proposed merger, Axonyx and TorreyPines
Therapeutics intend to file relevant materials with the Securities and
Exchange Commission (SEC), including a registration statement on Form S-4
that will contain a prospectus and a joint proxy statement. Investors and
security holders of Axonyx and TorreyPines Therapeutics are urged to read
these materials when they become available because they will contain
important information about Axonyx, TorreyPines Therapeutics and the
merger. The proxy statement, prospectus and other relevant materials (when
they become available), and any other documents filed by Axonyx with the
SEC, may be obtained free of charge at the SEC's web site at sec.
In addition, investors and security holders may obtain free copies of the
documents filed with the SEC by Axonyx by directing a written request to:
Axonyx, 500 Seventh Avenue, 10th Floor, New York, NY 10018, Attention:
Investor Relations. Investors and security holders are urged to read the
proxy statement, prospectus and the other relevant materials when they
become available before making any voting or investment decision with
respect to the merger.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to buy any
securities, nor shall there be any sale of securities in any jurisdiction
in which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
jurisdiction. No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities Act of
1933, as amended.
Participants in the Solicitation
Axonyx and its directors and executive officers and TorreyPines
Therapeutics and its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders of Axonyx
in connection with the proposed transaction. Information regarding the
special interests of these directors and executive officers in the merger
transaction will be included in the proxy statement/prospectus referred to
above. Additional information regarding the directors and executive
officers of Axonyx is also included in Axonyx's Annual Report on Form 10-K
for the year ended December 31, 2005, which was filed with the SEC on March
16, 2006. This document is available free of charge at the SEC's web site
(sec) and from Investor Relations at Axonyx at the address
described above.
This press release contains and the presentation made at the conference
may contain forward-looking statements or predictions, including statements
regarding the potential closing of the proposed merger between Axonyx and
TorreyPines Therapeutics and the combined company resulting from the
merger.
Actual results may differ materially from the above forward-looking
statements due to a number of important factors, including the possibility
that the proposed merger may not ultimately close for any of a number of
reasons, including, but not limited to, Axonyx not obtaining shareholder
approval of the issuance of shares and warrants in the merger, the change
in control resulting from the merger or the reverse split of Axonyx common
stock; TorreyPines Therapeutics not obtaining shareholder approval of the
merger, the possibility that NASDAQ will not approve the listing of the
combined company's shares for trading on the NASDAQ Stock Market or that
the combined company will not be able to meet the continued listing
requirements after the closing of the merger; that Axonyx and TorreyPines
Therapeutics will forego business opportunities while the merger is
pending; that prior to the closing of the proposed transaction, the
businesses of the companies, including the retention of key employees, may
suffer due to uncertainty; and even in the event the transaction is
completed, that combining Axonyx and TorreyPines Therapeutics may not
result in a stronger company, that the technologies and clinical programs
of the two companies may not be compatible and that the parties may be
unable to successfully execute their integration strategies or realize the
expected benefits of the merger.
Risks and uncertainties that could materially affect Axonyx are
described in the documents Axonyx files from time to time with the SEC,
including Axonyx's annual report on Form 10-K. Statements with regard to
product candidates of either Axonyx or TorreyPines Therapeutics are subject
to risks and uncertainties relating to development, regulatory approval and
commercialization, including whether any preclinical studies or clinical
trials, either ongoing or conducted in the future, will prove successful,
and if successful, whether the results can be replicated; whether 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; whether pre-clinical results will be substantiated by
ongoing or future clinical trials, if any, or whether any of its drug
candidates will be able to improve the signs or symptoms of their
respective clinical indication; whether 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; or whether the necessary
financing to support its drug development programs will be available.
Neither Axonyx nor TorreyPines Therapeutics undertakes any 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.
TorreyPines Therapeutics, Inc.
torreypinestherapeutics
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