RespireRx Pharmaceuticals Inc (RSPI)

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Cortex Pharmaceuticals Receives FDA Permission to Commence Phase II Alzheimer's Disease Imaging Study with AMPAKINE CX717
Monday January 31, 9:00 am ET
Cortex Directors and Executive Officers Must Purchase and Hold 30,000 Common Shares

IRVINE, Calif.--(BUSINESS WIRE)--Jan. 31, 2005-- Cortex Pharmaceuticals, Inc. (AMEX:COR - News), announced the U.S. Food and Drug Administration (FDA) has accepted the Company's 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 offer Cortex 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 Transnational Corporation, a large and well-respected global pharmaceutical services 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, as well as the sleep deprivation study currently underway in the UK, are the key programs to ascertain the efficacy of CX717 and to validate the primate model used to identify potential drug candidates.

On another topic, the Company reported the implementation of a common stock ownership policy recently approved by the Board of Directors, in which all members of the Board of Directors and Executive Officers must purchase and hold no less than 30,000 common shares of Cortex stock. Under this new policy all directors and executives of the Company must acquire and hold these common shares within three years. According to Dr. Stoll, Chairman of the Board, "This Policy was approved unanimously to better align the interests of the Company's Directors and Executives with the financial interests of the shareholders of the Company. It is the philosophy of the Company that no one should be in a significant management or directorship position without having a solid ownership position in Cortex."

About Cortex Pharmaceuticals and Its Partners:

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. Cortex has granted to Organon an exclusive license to commercialize its lead AMPAKINE®, Org 24448, for the treatment of schizophrenia and depression on a worldwide basis. This compound is currently being evaluated as a monotherapy to treat schizophrenia in a large Phase II trial and the company will shortly start to enroll schizophrenic patients in a large Phase II trial, where Org 24448 will be dosed in combination with traditional antipsychotics to improve the memory and cognition components of the disease that is not very responsive to current treatments, according to a joint press release by the National Institute of Mental Health and Organon on January 24, 2005. Servier' lead AMPAKINE like compound, S18986 has just entered early Phase II studies for their respective indications cited above. Cortex has granted to Servier a license to commercialize a limited number of AMPAKINE compounds in Europe, Africa, Middle East, Asia and three South American countries. (http://www.cortexpharm.com/)