Company Press Release SOURCE: Cortex Pharmaceuticals, Inc. Cortex Reports its Ampakines Increase Levels of Two Critical Proteins Required For Healthy Brain Cells Discovery May Have Significant Implications for Treating Several Brain-Related Disorders IRVINE, Calif., Nov. 9, 1998 /PRNewswire/ -- Cortex Pharmaceuticals, Inc. (Nasdaq: CORX - news) today announced that researchers from the University of California, Irvine (UCI) presented data that Ampakine(R) treatment increased levels of two important proteins required for healthy nerve cells, Brain Derived Neurotrophic Factor (BDNF) and Nerve Growth Factor (NGF). The presentation was made at the 28th Annual Meeting of the Society for Neuroscience being held in Los Angeles, California. Christine Gall, Ph.D., and Professor of Anatomy and Neurobiology led the UCI team that used experiments with brain slices in culture and in live animals. For a number of years, it has been known that BDNF and NGF can stimulate the growth of nerve cells in culture. Several companies have attempted to use BDNF and NGF produced by recombinant DNA technology to treat neurological diseases, including amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). However, direct administration of these proteins to patients has not been particularly successful. The UCI investigators found statistically significant increases in both gene expression (the production of messenger RNA) and protein synthesis of BDNF and NGF as a result of treatment with Ampakines. ``Demonstrating that it is possible to increase the activity of these genes by administering an Ampakine represents a major accomplishment,'' stated Vincent F. Simmon, Ph.D., President and CEO of Cortex, and a sponsor of the UCI study. ``As animals and humans age, the production of these important compounds is known to decrease. Furthermore, low levels of BDNF and NGF are known to be associated with increased susceptibility to toxic events and nerve cell death. One important aspect of the study was the demonstration that the production of these proteins could be increased in middle-aged animals.'' ``One of the current clinical trials being conducted by Cortex is in patients with mild to moderate Alzheimer's disease. If Ampakines can elevate the levels of BDNF and NGF in critical areas of the brain in this patient population, it may have the effect of slowing down disease progression,'' said Gary Lynch, Ph.D., and Professor of Psychobiology at UCI and a co-author of the UCI study. Professor Lynch also noted that these proteins might play an important role in the treatment of diseases such as Huntington's disease, Parkinson's disease, and in recovery from stroke or brain trauma. Ampakines are organic chemical molecules that can be taken by mouth and which rapidly enter the brain. In laboratory memory studies, Ampakines have been shown to increase the ability of animals to learn a variety of tasks that are commonly used to measure memory enhancement. Importantly, in the studies reported by Dr. Gall, production of BDNF and NGF were found to be elevated in specific areas of the brain known to be involved in learning and memory. Separately, on November 10th, Steven Johnson, Ph.D. will report that both CX516 and CX691, a more potent second-generation Ampakine, are capable of turning up BDNF and NGF gene expression in the brains of live laboratory animals. Cortex investigators led by Dr. Johnson administered these Ampakines to laboratory rats for two weeks, then determined the levels of BDNF and NGF in the animals' brains. The results demonstrated that daily Ampakine administration resulted in sustained elevation of BDNF and NGF gene expression. A preliminary Phase I clinical study was recently completed with CX691. 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 Ampakines, which act to increase the strength of signals at connections between brain cells. Aberrant neural connections or loss of these connections is believed to be responsible for the memory difficulties associated with Alzheimer's disease and to contribute to the memory and cognitive dysfunction seen in schizophrenia. Health industry estimates indicate that more than four million Americans are victims of Alzheimer's disease, with that number expected to double over the next 20 years as the U.S. population ages. SOURCE: Cortex Pharmaceuticals, Inc. -- Judith Richards, London, Ontario, Canada <[log in to unmask]> ^^^ \ / \ | / Today’s Research \\ | // ...Tomorrow’s Cure \ | / \|/ ```````