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| |  Ampalex Found to Have Positive Effects on Memory Deficits in Alzheimer's IRVINE, Calif., June 19, 1996 -- Cortex Pharmaceuticals, Inc. (Nasdaq: CORX) today announced the results of the third in a series of double-blind, placebo-controlled human studies with AMPALEX(TM) (CX516). Cortex is developing AMPALEX for the potential treatment of memory deficits in the early stages of Alzheimer's disease. The drug was found to be safe and well-tolerated by the healthy young volunteers in this study. Measures of learning and memory performance revealed significant improvement in the AMPALEX group in comparison to placebo. In announcing the results, Vincent Simmon, Ph.D., Cortex President and Chief Executive Officer, said "This study confirms that AMPALEX is safe and well-tolerated on acute oral administration to healthy volunteers, and provides important additional evidence of positive effects on performance on tasks of learning and memory. On the basis of these results, we plan to initiate additional studies in the target patient population, those experiencing deficits of memory and cognition in the early stages of Alzheimer's disease." AMPALEX was safe and well-tolerated by all volunteers receiving drug, with no adverse events reported. All laboratory values and measures of brain and cardiac function were within normal limits. Significant improvements in performance on measures of learning and memory were noted in the drug group. On a picture association task, volunteers receiving AMPALEX had significantly better delayed recall than those receiving placebo. Enhanced learning and memory was also suggested by an odor recognition task, with the drug group demonstrating significantly better recall of difficult odor pairs on drug days in comparison to placebos. The study, which involved 24 healthy young volunteers, was conducted at the Karolinska Hospital in Stockholm under the direction of Dr. Martin Ingvar. The 12-volunteer placebo group received placebo on all study days (1 to 5), while the 12-volunteer drug group received 300 mg of AMPALEX orally on days 2 and 3 and placebo on days 1, 4 and 5. Evaluations were conducted at the time of screening for inclusion in the study, immediately prior to study commencement, on each of five consecutive study days, and at a one-week follow-up appointment. Cortex, located in Irvine, California, is a neuroscience company focused on the development of drugs for the treatment of neurological and psychiatric disorders. The primary programs at the Company are centered on AMPAKINEs(TM), a family of orally-available compounds that enhance the functioning of the AMPA receptor, which is believed to be critical for memory formation and which is involved in most "excitatory" communication in the human brain. Cortex is developing AMPAKINEs for potential use in the treatment of deficits of memory and cognition due to Alzheimer's disease and in the treatment of schizophrenia. The Company is also investigating the potential use of calpain inhibitors in the treatment of stroke and cerebral vasospasm. Note: This press release contains forward-looking statements. Actual results may differ materially, depending on a number of risk factors, including the risk that AMPAKINEs may at any time be found to be toxic or ineffective for any or all of their proposed indications. As discussed in the Company's Securities and Exchange Commission filings, the Company's products, including AMPAKINEs, will require additional research and development, extensive clinical testing and regulatory approval, which approval is subject to various regulatory requirements and which can be lengthy.
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