Preliminary analysis of a pivotal phase III trial of Neotrofin, once thought to be a promising approach to stimulating growth of nerve cells, showed that the drug did not produce the hoped-for improvement in human patients with Alzheimer's disease.

Although the drug showed promise in animal trials (see earlier Medical Week story), it "failed to achieve statistical significance" over a placebo in treatment of Alzheimer patients, according to the drug's maker, NeoTherapeutics, Inc.

More than 500 patients with probable Alzheimer's disease were enrolled in the trial. During the first 12 weeks, half of the patients were on the drug and half on a placebo. During the second 12 weeks, those on the placebo were given the drug.

"We are disappointed that the study did not produce statistically significant results at 12 weeks that would support regulatory approval in Alzheimer's disease," said Alvin J. Glasky, Ph. D., Chairman and Chief Executive Officer of NeoTherapeutics.

"We will await further phase II analysis, as well as results from our ongoing phase II studies of Neotrofin in other indications … prior to moving forward with additional clinical studies of Neotrofin," he said.

Phase II studies of Neotrofin currently are underway for treatment of Parkinson's disease, spinal cord injury and chemotherapy-induced neuropathy, with results expected in 2003.

Other Sources: NeoTherapeutics, Inc.