TorreyPines Therapeutics Initiates Second Phase I Study For NGX267, A Selective M1 Agonist For Treatment Of Alzheimer's Disease

TorreyPines Therapeutics, Inc. today
announced that it has initiated a Phase I single and multiple dose study in
healthy elderly volunteers for NGX267, a novel treatment for Alzheimer's
disease. This study follows successful completion of the company's first
Phase I study with this compound. In the first study, NGX267 was administered
as single doses to healthy adult males and it was shown to be well-tolerated.
In preclinical studies, NGX267, a selective muscarinic (M1) agonist, has shown
the potential to both reduce symptoms and slow disease progression.


Designed in two parts, this double-blind, placebo-controlled study is
being conducted at one center in the U.S. The study will enroll approximately
64 healthy men and women between the ages of 65 and 80, reflecting the age of
the primary Alzheimer's disease population. The first part of the study uses
a single, ascending dose, sequential cohort design followed by a multiple dose
phase. Investigators will evaluate the safety, tolerability and single and
multiple dose pharmacokinetics of NGX267, as well as pharmacodynamic measures
including effects on CSF levels of AB1-42 and neuropsychological tests. This
second Phase I study is scheduled to complete in mid-2006.


"We believe our M1 agonist has the potential to offer disease modification
as well as symptomatic relief without the level of side effects previously
found with other M1 agonists," said Neil Kurtz, M.D., President and Chief
Executive Officer of TorreyPines. "A therapy that targets both the cause and
symptoms of Alzheimer's disease would be a significant breakthrough in the
treatment of this devastating illness."


Preclinical data support a dual mechanism of action for NGX267. The
compound has been shown to stimulate M1 receptors in a fashion analogous to
acetylcholine, a neurotransmitter essential for memory and cognitive function
that is depleted when neurons, or brain cells, degenerate. In addition, in
studies in mice and rabbits, NGX267 lowered brain levels of AB1-42, a toxic
peptide that is the major component of amyloid plaques. The amyloid plaque is
considered to be the primary hallmark of Alzheimer's disease.


Currently approved Alzheimer's disease therapies treat symptoms of the
disease only. These therapies have not been shown to reduce AB1-42 levels in
man, nor treat the underlying cause of the disease. NGX267 data also suggest
a high level of pharmacological specificity, which may provide better
tolerability than other M1 agonists that have been studied.


About TorreyPines Therapeutics


TorreyPines Therapeutics, Inc. is a biopharmaceutical company that
discovers and develops breakthrough small molecule drugs to treat diseases and
disorders of the central nervous system. Led by an accomplished management
team, the company is leveraging novel drug targets and technologies to deliver
new therapies for Alzheimer's disease, severe migraine and neuropathic pain.
Its breakthrough therapies are intended to offer significant advantages over
current therapies. Further information is available at
torreypinestherapeutics.


This news release contains certain forward-looking statements that involve
risk and uncertainties. Such statements are only predictions and the
company's actual results may differ materially from those anticipated in these
forward-looking statements. Factors that may cause such differences include
the risk that products that appeared promising in early research and clinical
trials do not demonstrate safety or efficacy in larger-scale clinical trials
and the risk that the company will not obtain approval to market its products.


TorreyPines Therapeutics, Inc.

torreypinestherapeutics