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| |  Ampalex Produces Cognition Improvement In Schizophrenia Patients SANTA FE, NM -- April 19, 1999 -- Research presented yesterday reveals that Cortex Pharmaceuticals, Inc.’s Ampalex(R), an experimental drug for use in the treatment of schizophrenia, produces statistically significant effects in cognition improvement. The results were presented at the International Congress on Schizophrenia Research yesterday by Donald Goff, M.D., principal investigator and director of the psychotic disorders program at Massachusetts General Hospital. The double blind, placebo-controlled four-week study was intended to evaluate the safety of combining Ampalex with clozapine, a commonly used anti-psychotic medication. The drug was evaluated in 19 patients with schizophrenia. Dr. Goff reported that Ampalex was well tolerated and did not induce any significant adverse effects. "Ampalex appears to have improved a number of aspects of cognitive function as measured by a battery of neuropsychiatric tests," Dr. Goff said. "Patients receiving the drug exhibited improvements in performance on tests of verbal learning and memory, problem solving, and distractibility. The magnitude of improvement in the California Verbal Learning Test was particularly impressive. This test is an excellent predictor of the ability of patients to return to normal function. "We have not yet completed our analysis of the results. However, it appears that a statistically significant improvement was also obtained in some clinical scales, including the Scale for Assessing Negative Symptoms measurement of attention and the Abnormal Involuntary Movement Scale. Although the number of patients in the study was not large, there was a consistent pattern of improvement in cognitive measurements, which makes the results compelling." Ampalex is one of the new Ampakine(R) class of drugs Dr. Goff added that the researchers are also intrigued by the observation that the improvements seen in Ampalex-treated patients appeared to persist for a period of time after the cessation of treatment. "Approximately 1% of the world's population suffers from schizophrenia," Dr. Goff said. "Available therapies treat so-called positive symptoms, such as hallucinations and delusions and, to some degree, negative symptoms, such as apathy and social withdrawal. None of the approved medications show clinically meaningful improvements in the cognitive impairments associated with the disease." "We are very encouraged because these results exceeded our expectations," said Gary Lynch, Ph.D., professor in psychiatry at the University of California Irvine, a co-author of the presentation. "We were hopeful of showing that Ampakines were safe when combined with clozapine and would show cognitive improvements. The breadth and consistency of cognitive improvements was surprising as were the clinical improvements." Related Links: Ampalex, Cortex Pharmaceuticals, Inc.
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