Trial of Higher Doses of Neotrofin for Alzheimer's Gets Underway

NeoTherapeutics announced completion of enrollment in their pivotal trial of higher doses of Neotrofin, a drug shown in previous studies to improve memory and behavior in patients with mild to moderate Alzheimer's disease.

Enrollment has reached 521 patients at 51 clinical sites around the nation in the double-blind, placebo-controlled study of Neotrofin. All 521 patients are currently taking Neotrofin or placebos.

All patients are expected to complete the first 12 weeks of the study by November 2001, and results are expected to be announced during the first quarter of 2002. Enrollment and randomization of the patients in the study was completed about 2 months ahead of schedule.

"The rapid pace of enrollment in this trial reflects the excitement among Alzheimer's clinicians, patients and caregivers about Neotrofin and the hard work of our in-house clinical management team," said Dr. F. Jacob Huff, Vice President, Medical Affairs of NeoTherapeutics.

"We are grateful to the 51 clinics and their staffs, who participated enthusiastically in this trial, and enable us to surpass our enrollment time-line objective by one-third. We also appreciate the interest and effort of the more than 700 Alzheimer's patients and their caregivers who went through the screening process. It is our greatest hope that the results of this trial will be a major step toward providing relief to those who suffer from this terrible disease."

The study will evaluate the effectiveness of higher doses in treating symptoms of Alzheimer's disease. The study incorporates 12 weeks of treatment for the primary analysis, followed by 12 weeks of treatment that allows patients initially given a placebo to receive Neotrofin. During the first 12 weeks, patients receive 500 mg. of Neotrofin or a placebo twice each day for one week. They then receive 1,000 mg. of Neotrofin or a placebo twice per day for 11 weeks, as long as there has not been any adverse reactions during the first week of therapy.

To date, nearly all patients who have completed the first week have been escalated to the higher dose with good tolerability.

In a phase 2 clinical study conducted at the Brain Imaging Center at the University of California, Irvine, patients given 500 and 1,000 mg. doses of Neotrofin showed statistically significant improvement in memory, attention and judgment. These improvements were consistent with changes in brain metabolism seen using PET scanning and changes in brain waves using electroencephalography.

A second and longer-term study is planned for 2002 in which disease course modification will be measured over one year of treatment, while effects on symptom improvement will be measured after 12 weeks of treatment.

NeoTherapeutics expects to file a New Drug Application for Neotrofin with the U.S. Food and Drug Administration in 2003.

Other sources: NeoTherapeutics