Healthcare Industry News: Organon
News Release - July 17, 2007
Cortex to Resume Clinical Trial with AMPAKINE(R) CX717 in Alzheimer-PET Scan Study after FDA Approves Protocol with Higher Doses of DrugIRVINE, Calif.--(HSMN NewsFeed)--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 double-blinded study will attempt to determine if we can duplicate the striking 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 naive 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."
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. (http://www.cortexpharm.com/)
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: Cortex Pharmaceuticals
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