From rxpgnews.com

Pharmacology
CX717 causes specific regional cerebral blood flow changes to improve cognition
By Akanksha,Pharmacology Correspondent
Feb 1, 2005, 10:04

The U.S. Food and Drug Administration (FDA) has accepted the Cortex Pharmaceuticals',CX717 investigational new drug (IND) application to initiate pilot Phase II clinical trials in the United States.

CX717 is being developed as a potential treatment for cognitive dysfunction that can arise from a variety of neuropsychiatric conditions including Alzheimer�s disease,attention-deficit hyperactivity disorder(ADHD),and sleep disorders.

"We are pleased by the timely response by the FDA and their permission for us to proceed with the proposed clinical investigation. In our IND application we submitted Phase I safety and pharmacokinetic data from nearly 100 healthy volunteers who were dosed with CX717 in studies that took place at Quintiles� Drug Research Unit in London," said Roger G. Stoll, Ph.D., Chairman, President and CEO of Cortex.

"CX717 was both well tolerated across a wide range of doses and exhibited simple, linear and predictable pharmacokinetic properties in these studies. We were also able to confirm that the drug had a 9 -10 hour half-life in these subjects, and that may provide Cortex with an opportunity to provide patients with a once a day therapy. We are appreciative of the efforts put forth by Cortex�s scientists and Quintiles, a large and well-respected global clinical research organization."

The first study of CX717 in the U.S. will be a double-blind, placebo-controlled study using Positron Emission Tomography (PET) imaging to determine the response of patients with Alzheimer�s disease, as well as healthy elderly volunteers, to CX717.

The study will look for changes in regional cerebral blood flow, which is a marker of brain activity. A positive effect with CX717 will build confidence that CX717 may have a therapeutic benefit in patients with Alzheimer�s disease.

In a similar study paradigm in primates, CX717 demonstrated specific activity in the prefrontal cortex, hippocampus and visual cortex, which are the key brain regions needed to improve memory, cognition and attention.The study in Alzheimer�s disease will be followed shortly thereafter with an Attention-Deficit/Hyperactivity Disorder (ADHD) trial.

CX717 is Cortex�s exclusive compound and excluded from existing partnerships. These studies, in addition to the currently ongoing sleep deprivation study in the U.K, are very important indications to the future of the Company.

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