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

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.

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.