>>IRVINE, Calif., Sept. 5 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT; NEOTW) announced today that 521 patients at 51 clinical sites around the United States have been enrolled in the Company's double-blind, placebo-controlled pivotal study of Neotrofin(TM) in Alzheimer's disease. All 521 patients are currently receiving Neotrofin or placebo, and all patients are expected to complete the first twelve weeks of this study by this November. Data will then be processed and analyzed, and results should be reported during the first quarter of 2002. Enrollment and randomization of patients was completed in approximately four months -- about two months ahead of projections.
``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 F. Jacob Huff, M.D, Vice President, Medical Affairs of NeoTherapeutics. ``We are grateful to the 51 clinics and their staffs, who participated enthusiastically in this trial, and enabled 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.''
``I am proud of the job that our clinical team has done on the design and enrollment of this pivotal Alzheimer's trial,'' stated Rajesh C. Shrotriya, M.D., President and Chief Operating Officer of NeoTherapeutics. ``A great deal of planning and input from some of the world's leaders in Alzheimer's disease went into the design of this trial. Excitement about our drug and hard work by our clinical team, as well as participating clinicians, led to the enrollment and randomization of over 500 patients in just four months.
``We believe that all of this will be accomplished for millions of dollars less than could have been done had the study been managed by a clinical research organization,'' added Dr. Shrotriya. ``This is secondary, though, to the hope that Neotrofin provides patients both as a potential symptomatic treatment and a potential disease-course modifying agent. To that end, we remain focused on getting the New Drug Application (NDA) filed for symptomatic treatment in the shortest time frame possible, and the rapid enrollment is most important in that regard.''
This clinical study, designed to be ``pivotal'' for registration, 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 in order to allow patients initially given placebo to receive Neotrofin. During the first 12 weeks, the protocol for this study calls for patients to receive 500 mg of Neotrofin or placebo twice per day for one week, and then to receive 1,000 mg of Neotrofin or placebo twice per day for eleven weeks, assuming no adverse reactions during the first week of dosing. To date, there have been no unexpected or serious adverse reactions. Nearly all patients who have completed the first week have been escalated to the higher dose, with good tolerability reported.
The primary endpoints for this study are the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), which measures memory and other cognitive deficits, and the Alzheimer's Disease Cooperative Study- Clinicians Global Impression of Change (ADCS-CGIC). There are four secondary endpoints consisting of standard memory and behavioral tests that are also being administered during the study. Entry criteria for the study includes an ADAS-cog score greater than 18 and a Mini-mental Status Exam (MMSE) score of between 10 and 24. These entry criteria are stricter than those used in the Company's previous Alzheimer's disease clinical studies, and ensure that patients meet the ``mild-to-moderate'' category for which it is believed that Neotrofin can show maximum benefit.
A second and longer-term pivotal study is planned to commence in 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. Assuming positive data from both the current and the second 12-week studies, the Company expects to file an NDA with the U.S. Food and Drug Administration (FDA) in 2003.
In previous human clinical studies, Neotrofin has been shown to improve memory and behavior in patients with ``mild-to-moderate'' Alzheimer's disease. Most recently, in a phase 2 clinical study conducted by Steven Potkin, M.D., professor of psychiatry and director of the Brain Imaging Center at the University of California, Irvine, patients treated with 500 and 1,000 mg doses of Neotrofin experienced statistically significant improvement in memory, attention and judgement. These behavioral improvements at the higher doses were consistent with changes in brain metabolism seen using Positron Emission Tomography scanning and changes in brain waves measured by electroencephalography.<<
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