SUMMARY: A new, large dose-ranging clinical trial of the drug Neotrofin ™ is being conducted to assess the efficacy of this drug as an Alzheimer’s treatment. Study participants consist of more than 1,500 patients diagnosed with mild to moderate Alzheimer’s disease. Participants will receive over six months of treatment. This Phase 2/3 clinical trial is expected to be finished by the end of next year.
ABSTRACT: NeoTherapeutics, Inc. announced today that it has initiated a new, large dose-ranging clinical trial of its novel therapeutic agent for Alzheimer’s disease, Neotrofin™(AIT-082, leteprinim potassium) in approximately 17 countries throughout the world.
This randomized, double-blind, placebo-controlled Phase 2/3 clinical trial is designed to study the efficacy of Neotrofin™ over six months of treatment in more than 1,500 patients with mild to moderate Alzheimer’s disease. Doses will be administered at four levels ranging from 25 to 150 milligrams and a placebo. The dosing levels were determined based upon the previously announced interim analysis of the Phase 2b worldwide trial. The study will be initiated in approximately 165 sites in 17 countries throughout the world. CroMedica, a leading, global contract research organization with extensive experience in Alzheimer’s disease, is conducting the study for NeoTherapeutics. This study is anticipated to be completed by the end of the year 2001.
“As a result of Neotrofin’s™ consistent positive clinical results to date, we have decided to take the next step in the drug approval process by initiating this dose-ranging study. The design of this clinical study fits into our aggressive clinical development plan for Neotrofin™ in patients with Alzheimer’s disease and addresses development and regulatory issues important in countries outside the United States,” stated Dr. Scott Wieland, Vice President, Product Development and Regulatory Affairs of NeoTherapeutics.
The Company currently has three additional clinical trials ongoing to study the effects of Neotrofin™ in patients with Alzheimer’s disease. The first study, conducted in Canada, South Africa and Australia, has already demonstrated on an interim basis that the administration of Neotrofin™ improves memory. The results of this study should be available in the late second quarter or early third quarter of this year. Results from the second study, conducted entirely in the United States with approximately 440 patients, should be available in the fourth quarter of this year. NeoTherapeutics is also conducting a small PET imaging study in patients with Alzheimer’s disease to determine cellular activity in different regions of the brain following oral administration of Neotrofin. The completion of these three clinical trials will provide a strong foundation for demonstrating and understanding the effects of Neotrofin™ in patients with 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™ causes the production of multiple natural nerve growth (neurotrophic) factors and restores function in animal models of cognitive decline, aging, neuroprotection, and spinal cord injury. Human clinical studies have demonstrated positive effects of Neotrofin™ on memory and behavioral function in patients with Alzheimer’s disease.
Drugs such as Aricept®, developed by Eisai and marketed by both Eisai and Pfizer, and the soon to be marketed Exelon®, developed by Novartis, have already been approved for the treatment of symptoms of mild to moderate Alzheimer’s disease. NeoTherapeutics’ research program is focused on designing and developing small molecules capable of treating a range of neurological diseases and conditions such as Alzheimer’s and Parkinson’s diseases, stroke, and spinal cord injury.
Source: NeoTherapeutics, Inc.,