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http://www.pslgroup.com/dg/3362e.htm ------------------------------------------------------------------------ Memory Improved In Alzheimer's Patients ------------------------------------------------------------------------ IRVINE, CALIF. -- July 29, 1997 -- Additional interim results from a Canadian Phase I/II trial demonstrate that an experimental drug which enhances nerve cell function by increasing levels of neurotrophic factors in damaged or degenerating neurons achieves improvement in memory function of Alzheimer's disease patients. Results from the 10-patient, single-dose, double-blind, placebo-controlled trial indicate that AIT-082, developed by NeoTherapeutics, Inc., was orally absorbed, produced no serious side effects and improved memory function. These results were reported today at the Second International Conference on Neurodegeneration in Princeton, New Jersey. Memory function was measured by the Word Recall Test after oral administration of AIT-082 at doses ranging from 500 to 4000 mg. At 180 minutes after oral drug administration, 60 percent of the patients treated with 500 or 1000 mg of AIT-082 showed improvement of memory function while 80 percent of the placebo-treated patients showed a decrease in memory compared to pretreatment levels. These differences were statistically significant. Patients receiving the highest doses did not exhibit improved memory function. The clinical trials are being administered under the direction of Dr. David William Molloy, an internationally recognized Alzheimer's researcher, at the Geriatric Research Group and Memory Clinic in Hamilton, Ontario, Canada. Patients were evaluated after receiving a single dose of AIT-082. Since Alzheimer's disease is a chronic degenerative process, further studies employing prolonged repeated treatment will be necessary before the true importance of these results can be established, the company said in a statement. The Company has initiated additional dose ranging Phase I/II studies in Canada employing lower doses of AIT-082 to determine the minimum effective dose. In addition, repeated dosing studies on larger numbers of patients will be needed to determine whether any adverse reactions or clinical benefits will result from long term administration of this drug. NeoTherapeutics' AIT-082 is a novel small molecule compound designed to cross the blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors in damaged or degenerating neurons. Neurotrophic factors are naturally occurring protein molecules that promote the growth, survival and regeneration of nerve cells within the body. Published studies have shown that AIT-082 increased levels of mRNA for the neurotrophic factors NGF, NT-3 and bFGF in cultured neurons, and that oral administration of AIT-082 produces a similar increase in neurotrophic factor production in the brains of aged animals.