Cortex’s AMPAKINE CX717 Toxicology Data Package Submitted To FDA
Data Demonstrates that Specific Histopathological Changes Found in Animal Toxicology Studies Occurred Postmortem
IRVINE, CA (April 18, 2007) — Cortex Pharmaceuticals, Inc. (AMEX: COR), sent two large data packages to the Food & Drug Administration (FDA) today regarding the Company’s lead Phase II Ampakine® product candidate, CX717. One data set went to the FDA’s Division of Neurology Drug Products and the other went to the Division of Psychiatry Products. The original CX717 Investigational New Drug (IND) was filed with Neuropharmacological Division (now Neurology Division) for the treatment of Alzheimer’s disease (AD) and the other data package went to the Psychiatry Division, where the Company intends to file a second CX717 IND for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The submitted data package provides clear evidence that the specific histopathological changes seen in animal toxicology studies, which previously caused the FDA to put CX717 on clinical hold, is a postmortem fixation artifact and is not found in the tissue of the animal when it is still living.
Dr. Roger Stoll, Chief Executive Officer of Cortex, stated, “When CX717 was removed from clinical hold on October 6, 2006 by the Neurology Division a dose was permitted for continuing a study in patients with AD, but that dose was too low to permit the assessment of the drug in patients with ADHD. Further information was needed to better understand the cause of the histopathological changes.” Dr. Stoll added that, “We now have a substantial data base which clearly documents the fact that the histological changes of concern occur postmortem when the fixative solution is used to prepare the slides of the tissue specimens.”
In early March 2006 Cortex reported in a small pilot Phase II study, that CX717 had demonstrated positive clinical and statistical results on the primary endpoint, the ADHD rating scale and the sub-scales related to attention and hyperactivity which are used for the approval of all currently available ADHD treatments. Consistent with all previous studies involving over 220 patients and healthy adults, this study demonstrated that CX717 was safe, well tolerated, and produced no increase in heart rate, blood pressure or other cardiovascular side effects. Cortex intends to cooperate fully with the FDA and the Company must now wait to hear from the agency regarding their willingness to approve higher dose levels for studying CX717 in adults with ADHD, and the Company’s subsequent desire to proceed with a larger Phase IIb study for this indication.
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, 2006, and Cortex's other filings with the Securities and Exchange Commission. Cortex disclaims any intent or obligation to update any forward-looking statements.
Roger G. Stoll, Ph.D.
Erika Moran/Dian Griesel, Ph.D.