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| |  Neotrofin Effective In Alzheimer’s Disease Treatment IRVINE, CA -- June 2, 1999 -- Recently completed phase IIa clinical trial of NeoTherapeutics, Inc.’s Neotrofin(TM) in patients with Alzheimer's disease show that the drug produces significant clinical improvements in cognitive function, behavioural symptoms and disease severity. The data from this study was presented today at the 39th annual meeting of the New Clinical Drug Evaluation Unit (NCDEU), in Boca Raton, FL. Steven Targum, M.D., of Clinical Studies Ltd., the principle investigator of this clinical trial, presented data describing the use of NeoTherapeutics' novel drug as a potential treatment for patients with mild to moderate Alzheimer's disease. Seventy-five subjects were enrolled in the double-blind study which tested Neotrofin at three dose levels or placebo for 28 days of treatment. These subjects were evaluated again after a 28 day period in which no drug was given, to determine potential longer term effects of the drug. In patients with Alzheimer's disease, the Neotrofin treated group showed an improvement from baseline testing in the ADAS-cog, a measure of cognitive functioning, after 28 days of administration. Total ADAS-cog scores improved in 72 percent of patients receiving the 150mg dose. The Global Behave-AD test, a measure of behavioural symptoms such as aggressiveness and anxiety, revealed statistically significant positive differences between drug groups and the placebo group. Additionally, the CIBIC-plus, a measure of overall disease severity, demonstrated a marked improvement in the drug treated groups and the positive effects of the drug were observed for an additional 28 days after the drug was stopped. "Improvements in memory function and behaviour suggest that Neotrofin may have therapeutic benefit in patients with Alzheimer's disease," Dr. Targum said. "Larger studies of longer duration with Neotrofin are needed to ascertain the sustained cognitive benefit of this drug and evaluate the potential to modify the progression of Alzheimer's disease." Neotrofin is being developed for nerve repair and regeneration, with Alzheimer's disease as its first clinical indication. Pre-clinical studies have demonstrated that Neotrofin can control the production of multiple natural neurotrophic factors and restore function in animal models of aging, brain injury and spinal cord injury.
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