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New asthma nedication research from TorreyPines Therapeutics, Inc. The company announced that it has initiated a Phase I single and  multiple asthma medication treatment 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 new asthma medication 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 asthma medication treatment 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  http://www.torreypinestherapeutics.com.

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