December 18, 2000
NeoTherapeutics' Neotrofin(TM) Improves Brain Function in Alzheimer's Disease Patients, Clinical Study Shows
IRVINE, Calif., Dec. 18 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT; NEOTW) announced today clinical data from a study of its nerve regeneration drug, Neotrofin(TM), showed that the novel compound facilitates brain activity in Alzheimer's disease patients, leading to statistically significant improvement in memory, attention and judgement. Clinical data were presented at the 39th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in San Juan, Puerto Rico.
The double-blind, dose-escalating Phase 2 pilot study, conducted by Steven Potkin, M.D., professor of psychiatry and director of the Brain Imaging Center at the University of California, Irvine, evaluated 19 patients diagnosed with Alzheimer's disease who were treated with Neotrofin(TM).
Dr. Potkin reported that patients treated with Neotrofin(TM) experienced statistically significant improvement in three areas: memory, attention and judgement ( "executive function''). The improvement was dose related, with 500 mg and 1000 mg doses producing statistically more benefit than the 150 mg dose. These functional improvements were demonstrated by a multi-faceted battery of neurocognitive tests. Positron Emission Tomography (PET) scanning, which measures the metabolic activity of the brain, and electroencephalography (EEG), which measures brain waves, on the same patients, were consistent with improvement following Neotrofin(TM). The findings of this study support NeoTherapeutics' recently announced decision to initiate early next year a one-year clinical study at doses of 500 mg and 1000 mg in patients with moderate Alzheimer's disease.
"The clinical symptoms that were affected positively by Neotrofin(TM) -- memory, attention and judgement - are hallmarks of Alzheimer's disease,'' said Dr. Steven Potkin. "The positive changes in these symptoms were associated with increased metabolism in specific brain areas on PET scans. In addition, there were no serious side-effects reported by the patients.''
"The results of Dr. Potkin's clinical study validate our contention that Neotrofin(TM) is perhaps the first Alzheimer's disease therapy that stimulates nerve cell regeneration in the brain leading to disease course modification,'' said Rajesh Shrotriya, M.D., president of NeoTherapeutics. "The findings of Dr. Potkin's study show us that Neotrofin(TM) works, and together with the important results from our Phase 2b U.S. and Global clinical trials, provides us with the information we needed to properly design a large, long-term clinical study to demonstrate the drug's effectiveness for regulatory purposes. That trial is presently being designed, and after we reach agreement with the FDA on the protocol early next year, we will begin enrolling patients. With evidence such as this, it is easy to see why moving forward with clinical studies for Neotrofin(TM) in patients with Alzheimer's disease, Parkinson's disease and spinal cord injury remains our highest priority.''
"Especially gratifying is that the results of Dr. Potkin's study were presented at the ACNP meeting, an exclusive gathering of the preeminent experts in the field of neurology, psychiatry and neurodegenerative diseases, where attendance is limited to selected members and invitees,'' added Dr. Shrotriya.
NeoTherapeutics is a biopharmaceutical company focused on the development of small molecule drugs for unmet medical needs for the treatment of important diseases. The Company's most advanced drug, Neotrofin(TM), is currently being developed for Alzheimer's disease and other neurodegenerative diseases, such as Parkinson's disease and Spinal Cord Injury. In animal models of cognitive decline, aging and spinal cord injury, Neotrofin(TM) has been shown to restore neurological function. NeoGene Technologies, Inc., a subsidiary of NeoTherapeutics, is engaged in functional genomics research. NeoOncoRx, Inc., a subsidiary of NeoTherapeutics, is engaged in the development of anticancer drugs. For additional Company information, visit NeoTherapeutics' web site at www.neotherapeutics.com.
This press release may contain 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.
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