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Cortex Commences Enrollment in Two Additional Phase IIa Studies With AMPAKINE CX717; ADHD and Alzheimer's Disease Studies Are Underway

Posted on: Thursday, 28 July 2005, 09:00 CDT

Cortex Pharmaceuticals, Inc. (AMEX: COR) announced today that it began enrollment in the second and third AMPAKINE(R) CX717 Phase IIa studies: one in Attention Deficit Hyperactivity Disorder (ADHD) and the other in mild to moderate Alzheimer's disease (AD). The fourth Phase IIa study, in simulated night shift work is scheduled to start enrollment at the end of August. In May 2005, the Company reported positive results in its first Phase IIa study with CX717. The study suggested that CX717 may provide a new approach to enhancing memory cognition and wakefulness by cortical arousal without systemic stimulating effects.

According to Dr. Hank Mansbach, VP of Clinical Development and Chief Medical Officer at Cortex, the ADHD study will enroll 60 adult patients in randomized double-blind design, which will evaluate two doses of CX717 (200mg bid and 800mg bid) and placebo in a two period crossover design. The primary outcome measures will be the change from baseline on the ADHD Rating Scale. Quintiles Transnational has been engaged as the Clinical Research Organization (CRO) to run this study. The protocol being utilized in this study has been used successfully by several medications (Adderall(R), Concerta(R) and Straterra(R)) that are currently marketed for this disorder.

The second study involves the evaluation of two single doses of CX717 (200mg and 600mg versus placebo) in a randomized, double-blind study of twelve subjects with mild to moderate Alzheimer's disease and matched controls. Dr. Mansbach stated the main hypothesis is that CX717 will positively alter regional cerebral blood flow in patients with AD during the performance of an activating task. This study should help build confidence in the potential of CX717 prior to the Company undertaking a larger Phase II study in AD.

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. www.cortex.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: Business Wire

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