SAN DIEGO, Feb. 27 /PRNewswire/ -- 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 www.torreypinestherapeutics.com .
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.
CONTACT: Evelyn Graham of TorreyPines Therapeutics, Inc., +1-858-623-5665,ext. 118, egraham@torreypinestherapeutics.com; or Media, Tony Loke,+1-917-322-2164, tloke@RxIR.com, or Investors, Rhonda Chiger,+1-917-322-2569, rchiger@RxIR.com, both of Rx Communications, forTorreyPines Therapeutics, Inc.
Web site: http://www.torreypinestherapeutics.com/
