Update on Cortex's CEO Presentation at the Roth Capital Partners 19th Annual Conference
After earlier preclinical histopathological tissue results were reviewed by the FDA, the agency initiated a clinical hold for CX717 in March 2006. At the request of the FDA, Cortex conducted extensive additional animal toxicology studies during the summer of 2006 and in October 2006 the agency lifted the clinical hold, but placed significant dosage limitations on the use of CX717 in clinical trials. These limitations meant that Cortex could not proceed with further clinical assessments of CX717 in ADHD patients. CX717 had earlier demonstrated positive results in a pilot ADHD study in adult patients in a pilot Phase IIa study in March 2006. Cortex is planning to submit this new preclinical data to the FDA in March with a request to have the dosage limitations changed so that it can proceed to conduct further clinical trials of CX717 in adult ADHD patients. Dr. Stoll, the Chief Executive Officer of Cortex, cautioned that the final decision on the adequacy of the data to allow the Company to proceed clinically is up to the FDA.
Dr. Stoll also mentioned during his presentation that the FDA had just issued a notice that will require that all current manufacturers of ADHD drugs issue Patient Medication Guides that spell out the risks of the current medications with respect to cardiovascular and psychiatric adverse events observed with the currently approved therapies. Dr. Stoll noted that the potential for a new therapeutic approach to the treatment of ADHD is clear and, if clinically safe and effective, CX717 could meet many of the current market needs. Dr. Stoll reiterated that the 3-week study in adult ADHD patients randomized to either CX717 or placebo, in a cross-over design, was both clinically and statistically significant on both decreasing hyperactivity and increasing attention on the primary ADHD rating scale which is the primary measure by which all ADHD products are approved.
Another point made by Dr. Stoll during the presentation at the Roth Conference was that the most recent studies by Dr. Gary Lynch at UC Irvine using a high impact AMPAKINE drug, CX929, showed very encouraging results in transgenic mice with the Huntington's Disease gene. CX929 not only returned depressed levels of BDNF (brain derived neurotrophic factor) back to normal, restored long term potentiation and most recently showed significant improvements in behavioral effects in the transgenic mouse model.
The remaining topics covered by Dr. Stoll included an update on the low-impact AMPAKINE CX701 which Cortex anticipates commencing clinical trials by July 2007, the likelihood of a new research and development collaboration for its high-impact AMPAKINE compounds, and the in-licensing of a new Phase II non- AMPAKINE orphan drug.
A replay of the presentation will be available for 30 days and can be accessed via the following link: http://www.wsw.com/webcast/roth9/cor/.
More information regarding the conference can be found at http://www.rothconference.com/.
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(R) 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. For additional information regarding Cortex, please visit Cortex Pharmaceuticals' Website at www.cortexpharm.com.
NOTE -- THIS PRESS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS WITH RESPECT TO FUTURE REGULATORY ACTIONS BY THE FDA, INTERPRETATIONS OF PRE-CLINICAL TOXICOLOGY RESULTS AND ANTICIPATED RESULTS OF FUTURE CLINICAL TRIALS AND THE POSSIBLE CLINICAL USES OF AMPAKINE COMPOUNDS, ALL OF WHICH ARE DIFFICULT OR IMPOSSIBLE TO PREDICT ACCURATELY AND MANY OF WHICH ARE BEYOND THE CONTROL OF CORTEX, ALL AS MORE FULLY DESCRIBED IN THE RISK FACTORS AND OTHER MATTERS SET FORTH IN CORTEX'S ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2005, AND CORTEX'S OTHER FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. CORTEX DISCLAIMS ANY INTENT OR OBLIGATION TO UPDATE ANY FORWARD-LOOKING STATEMENTS.
Cortex Pharmaceuticals, Inc.
Roger G. Stoll, Ph.D., Chairman, President and CEO
The Investor Relations Group
Erika Moran/Dian Griesel, Ph.D., 212-825-3210
Janet Vasquez/Lynn Granito, 212-825-3210
Posted: February 2007