The full PR (or is it 'BS') for allowing AD:
Cortex to Resume Clinical Trial with AMPAKINE® CX717 in Alzheimer-PET Scan Study After FDA Approves Protocol with Higher Doses of Drug
IRVINE, Calif., July 17, 2007 — Cortex Pharmaceuticals, Inc. (AMEX: COR), announced that following review of the AMPAKINE® CX717 data package sent to the Food & Drug Administration’s (FDA) Division of Neurology Products (DNP) on April 17, 2007, the FDA responded that Cortex can immediately resume enrollment in the CX717 Alzheimer’s positron emission tomography (PET) scan study at all requested dose levels. The study was originally designed with doses of 200mg, 600mg, and 1200mg to be administered to the patients. However, the agency had previously limited the dose levels such that the 600mg and 1200mg doses could not be administered. The new protocol approved by the agency allows a return to the original dose levels, with the upper dose being 1200mg.
Dr. Roger Stoll, Chief Executive Officer of Cortex, stated, “With the removal of the dose restrictions, the Company can now resume studying CX717 at all desired dose levels. This important {is that so} double-blinded study will attempt to determine if we can duplicate the striking {nice adjective} PET scan findings in non-human primates which correlated with increased cognitive performance published by Dr. Deadwyler in PLOS Biology in September 2005.” The clinical study is being performed in mild-moderate Alzheimer’s patients who are drug naïve or stabilized on cholinesterase inhibitors at the University of Michigan Medical Center. In animal studies cholinesterase inhibitors such as Aricept® and Reminyl® appear to enhance the effects of CX717.
The earlier dose limitations imposed by the FDA were related to concerns over data from preclinical animal studies and were not related to any findings from human clinical trials. The DNP plans to continue their review of the data package, but saw no reason not to permit the full resumption of the current AD-PET scan study. Cortex will continue to have further discussions with the DNP regarding the previously submitted toxicology package and additional requirements may be requested by the FDA.
Cortex intends to file a second IND for CX717 with the Division of Psychiatry Products (DPP) during the 3rd Quarter of 2007 to allow the Company to initiate a Phase IIB study evaluating CX717 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Since the DNP was where the original clinical hold was issued and where the subsequent release of the clinical hold with dosage limitations was granted, Cortex recognized that a decision from that division of the FDA was needed before proceeding with a filing in another division (DPP) for the same drug product.
“We are gratified that all our hard work has succeeded in moving the development of CX717 forward and we have to thank some very diligent employees, consultants, and advisors for their help with this complicated issue,” added Dr. Stoll. “It is a credit to our researchers and our Company that an issue of such complexity could be unraveled and permit Cortex to proceed with the development of this new and novel treatment for some serious CNS diseases.”
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