Dott. Carlo Sebastiano Tadeo
RICHMOND, CA -- February 22, 2000 -- Neurobiological Technologies, Inc. (NTI(R)) announced that its corporate collaborator, Merz + Co. GmbH & Co. (Merz + Co.) of Frankfurt, Germany, has reported significant positive results from a U.S. Phase III trial of Memantine in patients with advanced Alzheimer's disease. As stated in their release dated February 18, 2000:
Merz + Co., an R & D-oriented pharmaceutical company, headquartered in
Frankfurt, Germany, announced first significant positive results of a US Phase
III clinical trial of Memantine in advanced Alzheimer's disease.
This randomized, 6-months placebo-controlled, double-blind multicenter trial
was aimed at functional improvement of patients with moderate to severe
Alzheimer's disease. An ADL-scale (ADCS) was used as functional endpoint,
combined with a global endpoint. The trial enrolled 252 patients in the US and
was jointly managed by Quintiles CNS Therapeutics. These latest significant
positive clinical trial results confirm the findings of the previously conducted
phase III clinical studies Merz + Co. conducted for registration
Dr Hans-Joerg Moebius, Vice President R & D Pharma, stated: "These
promising results represent a breakthrough in terms of significant patient and
caregiver benefit by the uncompetitive NMDA-antagonist Memantine in the untapped
therapeutic area of advanced dementia. In addition, compared to other
anti-dementia drugs, Memantine showed an excellent safety and tolerability
The principal investigator, Prof. Barry Reisberg, New York University Medical
Centre, plans to disclose the data at the 7th Alzheimer's Annual Meeting in
Washington, July 9th - 13th, 2000. Further results of two other
placebo-controlled phase III trials in mild to moderate vascular dementia
conducted in Europe (France and the United Kingdom) will be presented at the
Springfield Meeting in Stockholm, April 5th - 8th, 2000.
NTI(R) recently completed a placebo-controlled Phase IIB, dose-ranging human
clinical trial of Memantine in diabetics with painful neuropathy, daily dosing
of 40 mg Memantine which resulted in statistically significantly less nighttime
pain intensity compared to placebo. NTI and Merz + Co. expect to work with the
FDA to design a Phase III study for this indication. NTI will present the
complete results from this Phase IIB trial at the 52nd Annual Meeting of the
American Academy of Neurology in San Diego, April 29 - May 6, 2000.
NTI is an emerging drug development company focused on the clinical
evaluation and regulatory approval of neuroprotective drugs. The company's
strategy is to in-license and develop early-stage drug candidates that target
major medical needs and that can be rapidly commercialized. NTI is currently
developing Memantine for multiple neurological conditions and evaluating
Xerecept(TM) as a treatment for peritumoral brain edema.
Merz + Co. is a leading privately owned German pharmaceutical and central
nervous system research company that develops, manufactures and markets
pharmaceutical products worldwide. The company's Pharma Division markets
multiple products, including Akatinol Memantine(R) for the treatment of primary
dementia and PK-Merz(R) and PK-Levo(R) for Parkinson's disease.
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