Here is the latest press release. As I read it, the tests keep confirming the safety and efficacy of the drug and keep turning up additional benefits,like "....improvement increased as treatment continued ..." and low dosage levels. Doesn't that actually MEAN "reverses the degenerative process"? I'm not a scientist but, if there was a safe drug that stimulated the natural production of nerve growth and improved the communication between the brain cells and memory and, I suppose intelligence, I would think that would be a very big deal. Anyone know if that has been done in humans before?
NeoTherapeutics Announces Positive Interim Results Of NEOTROFIN Clinical Study in Alzheimer's Disease
IRVINE, Calif., Nov. 30 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT - news) announced today that, based on an analysis of interim data from its Phase 2b multi-center clinical trial, administration of NEOTROFIN(TM) resulted in improved memory. Despite the limited objectives of this interim analysis, the results indicated that doses of NEOTROFIN(TM), as low as 50 milligrams once a day, produced positive responses on the ADAS-Cog, a standardized measure of memory in patients with Alzheimer's disease. The improvement increased as the treatment continued for 90 days.
This study is currently being conducted in Canada, Australia and the Republic of South Africa in over 400 patients suffering from mild to moderate Alzheimer's disease. Patients are receiving NEOTROFIN(TM) at one of three dose levels for 90 days of treatment. The interim analysis was performed on approximately half of the patients who are participating in the study and who had completed 90 days of treatment. In order to perform the interim analysis and preserve the statistical strength of this study, an additional 100 patients are being added. Enrollment is due to be completed soon and results are expected near the end of the second quarter of 2000.
''Although these are interim results, the data supports NEOTROFIN(TM) as the next generation of therapy for Alzheimer's disease,'' said D. William Molloy, M.D. of Henderson Hospital, Hamilton, Ontario, Canada, the Principal Investigator for this global study. ''The data to date indicate that NEOTROFIN(TM) is having a clinical benefit on cognitive assessment tests, which is of great importance to patients and caregivers,'' continued Dr. Molloy.
''We are pleased with the results as they continue to validate the safety, tolerability and efficacy of NEOTROFIN(TM),'' said Scott Wieland, Ph.D., M.B.A., Vice President, Product Development and Regulatory Affairs of NeoTherapeutics. ''In addition, the interim results have provided important insights that will influence the design of future clinical trials to further strengthen NEOTROFIN's clinical development program.''
''We continue to be encouraged by NEOTROFIN's clinical effects,'' said Alvin J. Glasky, Ph.D., President, CEO, and Chief Scientific Officer of NeoTherapeutics. ''These interim results, as well as the results from six completed clinical trials, including the 75 patient phase 2a clinical trial, have demonstrated the safety and positive characteristics of NEOTROFIN(TM) on memory,'' Dr. Glasky continued.
NEOTROFIN(TM) is being developed for nerve repair and regeneration, with Alzheimer's disease as its first clinical indication. Pre-clinical studies have demonstrated that NEOTROFIN(TM) causes the production of multiple natural neurotrophic factors and restores function in animal models of cognitive decline, aging, brain injury, and spinal cord injury. Human clinical studies have demonstrated NEOTROFIN's safety and positive effects on memory and behavioral function in patients with Alzheimer's disease.
According to figures from the Alzheimer's Association, Alzheimer's disease presently affects over 4 million people in the U.S. and approximately 12 million patients worldwide, with associated health care costs of $80-$100 billion per year. Currently marketed drugs, such as Pfizer's Aricept® and Novartis' Exelon®, have been approved to slow the progression of symptoms of Alzheimer's disease.
NeoTherapeutics' research program is focused on developing small molecules capable of promoting nerve regeneration and repair for a range of neurological diseases and conditions such as Alzheimer's and Parkinson's diseases, stroke, and spinal cord injury. Additional compounds in NeoTherapeutics' product pipeline address other health issues such as obesity, migraine and depression. Recently, NeoTherapeutics has acquired the rights to research and potential products in the area of functional genomics. For additional Company information, visit the NeoTherapeutics web site at www.neotherapeutics.com.
It should be noted that the final results of this Phase 2b study and results of any future studies of NEOTROFIN(TM) might not confirm the interim results described in this press release. This press release contains forward-looking statements regarding future events and the future performance of NeoTherapeutics that involve risks and uncertainties that could cause actual results to differ materially. These risks are described in further detail in the Company's reports filed with the Securities and Exchange Commission.
For more information, contact: Investment Community: Carol Gruetter, NeoTherapeutics, Inc., 949-788-6700, e-mail: cgruetter@neotherapeutics.com; or Media: Kelly Finley, Halsted Communications, Inc., 800-600-7111 ext. 233, or 323-225-1835, e-mail: kfinley@halsted.com.
SOURCE: NeoTherapeutics, Inc.
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