Healthcare Industry News:  intended use 

Biopharmaceuticals Neurology Licensing

 News Release - October 6, 2010

Cortex Obtains Exclusive Worldwide Rights for the Combination of AMPAKINE(R) and mGluR5 Compounds for the Treatment of Fragile X

IRVINE, Calif.--(Healthcare Sales & Marketing Network)-- Cortex Pharmaceuticals, Inc. (OTCBB (CORX)) announced that the rights to a published patent application entitled, "Pharmacological Modulation of Positive AMPA Receptor Modulator Effects on Neurotrophin Expression" (PCT/US2007/066947), has been licensed exclusively to Cortex from the University of California.

This broad method-of-use patent application covers the combined use of AMPAKINE compounds and metabotropic glutamate receptor type 5 (mGluR5) antagonists for the treatment of Fragile X syndrome, the most common genetically proven cause of autism, and for the treatment of Parkinson’s disease, Huntington’s disease and other neurodegenerative disorders. “Early clinical studies with mGluR5 antagonists have shown promising results in Fragile X patients, and in animal studies the combination of these agents with our AMPAKINE compounds provides additional benefit via synergistic effects. If these effects hold up in clinical studies, the combination of these agents could be an important treatment option for Fragile X patients,” commented Dr. Mark A. Varney, President and CEO of Cortex.

The inventors, Drs Julie Lauterborn, Christine Gall, and Gary Lynch, are neuroscientists at the University of California, Irvine (UCI). Cortex provided the AMPAKINE compounds and financial support for these studies. The same neuroscientists at UCI have previously demonstrated that brain derived neurotrophic factor (BDNF) alone, when injected into the brain, can restore some of the deficits that occur in a mouse model of Fragile X mice. However, BDNF would need to be injected directly into the brain to have an effect. The UCI investigators demonstrated that oral or injected AMPAKINE compounds can increase the production of BDNF in the brain in Fragile X mice, but when combined with an mGluR5 antagonist, these increases in BDNF were larger. “This also raises the question of whether other disorders in which BDNF plays a role, such as Parkinson’s or Huntington’s disease, might benefit from the AMPAKINE and mGluR5 antagonist combination,” said Dr. Varney.

About Fragile X

Fragile X is the most common genetic disorder causing mental retardation in children. The faulty gene inhibits the production of a protein called FMRP, which is responsible for keeping levels of other neuronal proteins in check. The excess of some proteins that results from the FMRP deficit impairs brain development and causes Fragile X. In 2000, ground breaking research performed by Professor Mark Bear, then at Brown University and a team of neuroscientists demonstrated that blocking the production of glutamate with an mGluR5 antagonist helped counterbalance the effects of reduced FMRP levels. Currently there are several clinical studies underway with mGluR5 antagonists to determine if these compounds can reduce symptoms associated with Fragile X.

Cortex Pharmaceuticals, Inc.

Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for treating psychiatric disorders, neurological diseases and sleep apnea. Cortex 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. For additional information regarding Cortex, please visit the Company’s website at http://www.cortexpharm.com.

Forward-Looking Statement

Note — this press release contains forward-looking statements concerning the Company’s operating activities. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. The success of such activities depends on a number of factors, including the risks that the Company’s drug candidates may at any time be found to be unsafe or ineffective for their intended use, including the treatment of Fragile X or Parkinson’s disease; that the Company may have insufficient resources to undertake proposed clinical studies and that preclinical or clinical studies may at any point be suspended or take substantially longer than anticipated to complete; or that the patent applications licensed from UC do not result in enforceable patent rights. As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly preclinical and clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this press release. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.


Source: Cortex Pharmaceuticals

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