PipelineReview.com - Biotech News & Online Store - Cortex Reports Positive Results with CX717 on the Primary Outcome Measure in Adult ADHD Study; Conference Call Scheduled for 10:00 AM EST on March 8, 2006

Cortex Reports Positive Results with CX717 on the Primary Outcome Measure in Adult ADHD Study; Conference Call Scheduled for 10:00 AM EST on March 8, 2006

06 Mar 2006

IRVINE, CA, USA | Mar 06, 2006 | Cortex Pharmaceuticals, Inc.'s (AMEX: COR), lead AMPAKINE(R) drug, CX717, showed positive

results for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD). Forty-nine patients with ADHD completed the randomized, double-blind, placebo-controlled, two-way crossover design performed at seven US sites. Cortex undertook this Phase IIa clinical trial to assess both the dose of drug required and the effectiveness of CX717 in an adult ADHD population. The primary outcome measure was the ADHD Rating Scale (ADHD-RS) which evaluates both the inattentiveness and hyperactivity symptoms. The overall ADHD-RS score showed a positive trend in the 800mg twice daily (bid) dose group (n = 22) with a statistically significant effect on the hyperactivity subscale (p=0.050) compared to placebo. The 200mg bid dose (n = 27) did not show a significant effect. CX717 was well tolerated, and there were no serious adverse events or other significant safety concerns with either dose. Further, no increases in blood pressure or heart rate were observed on either dose of CX717.

"The results from this Phase IIa study in adults with ADHD show that CX717 provided a clinically relevant response on the ADHD Rating Scale though the results will need to be verified in a larger study," said Lenard Adler, MD, the lead investigator of the study, Director for the Adult ADHD Program, and Associate Professor of Psychiatry and Neurology at New York University School of Medicine. "I am encouraged by the performance of CX717 which could lead to the development of a new pharmacotherapy for the treatment of ADHD."

"We are delighted that we achieved a response with the 22 completers in the 800mg bid dose group," said Dr. Roger Stoll, Chairman & CEO of Cortex. "It goes without saying that further studies with CX717 will be conducted in larger patient populations to further define the therapeutic dose and frequency of dosing. We believe that the market may be very interested in a non-stimulant ADHD drug with reduced cardiovascular concerns, which CX717 might offer. Where previous results reported for CX717 were in sleep deprived, normal subjects, this is the first study we have completed in a patient population with CX717 and represents real progress for Cortex ."

ABOUT THE STUDY

The study was a randomized, double-blind, placebo-controlled, multi-center, 2-period crossover. Each subject received placebo during one treatment and either CX717 200 mg bid or CX717 800 mg bid in the other treatment period. Each treatment period was 3 weeks with a 2 week washout in between. Sixty-eight subjects were randomized of whom 65 took either CX717 or placebo. Of those 65, 49 completed all assessments in both treatment periods. Most subjects who withdrew did so for non-treatment related reasons. The results presented here are for the primary outcome measure (the ADHD-RS). Analyses of other parameters are ongoing.

ABOUT ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a common psychiatric disorder characterized by inattentiveness, poor impulse control and hyperactivity. The disorder was historically thought of as a childhood illness. Longitudinal studies however have documented the persistence of symptoms into adulthood in a large percentage of childhood sufferers. The prevalence of ADHD is estimated at 2 - 4% of adults. ADHD exacts a significant toll on social relationships, education, and vocational attainment. Relative to those without the disorder, adults with ADHD tend to have higher rates of divorce, lower grade point averages in school, lower graduation rates, lower socioeconomic status, and more frequent problems with unemployment

Conference Call

Cortex will host a conference call and webcast on Wednesday, March 8th, at 10a.m. EST, to discuss today's announcement. Following the conference call, the company will open the phone lines to answer questions from investors and members of the media. Those who wish to participate may do so using the following dial-in information: In the United States, call (877) 407-0782. Internationally, call (201) 612-7415. An audio replay of the conference call will be available through Friday, March 24, 2006 by dialing (877) 660-6853 for U.S. participants and (201) 612-7415 for international participants. When prompted, participants should enter pass code 286 and conference ID number 195248. For the webcast please use the following link: http://www.vcall.com/IC/CEPage.asp?ID=102220. A replay of the webcast will be available through March 24, 2006.

About Cortex Pharmaceuticals

Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer's disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain's neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease, including Mild Cognitive Impairment, Alzheimer's disease and anxiety disorders. (http://www.cortexpharm.com/)

Forward-Looking Statement

Note - This press release contains forward-looking statements concerning the Company's research and development activities. The success of such activities depends on a number of factors, including the risks that the Company's proposed compounds may at any time be found to be unsafe or ineffective for the indications under clinical test and that clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company's Securities and Exchange Commission filings, the Company's proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease.

SOURCE: Cortex Pharmaceuticals, Inc.

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