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Biotech / Medical : Neurobiological Tech (NTII) -- Ignore unavailable to you. Want to Upgrade?

To: JMarcus who wrote (783)	2/22/2000 10:08:00 AM
From: Dr. John M. de Castro	Read Replies (1) \| Respond to of 1494

Neurobiological Technologies, Inc. Announces Positive Results from Phase III Trial of Memantine for Moderately Severe to Severe Alzheimer's Disease RICHMOND, Calif., Feb. 22 /PRNewswire/ -- Neurobiological Technologies, Inc. (NTI®) (OTC Bulletin Board: NTII - news) today 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 requirements in Europe and the US. Significant positive results of a previous trial in the same population have been published by Prof. Bengt Winblad of the Karolinska Institute in Stockholm in 1999. 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 profile.'' 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® 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® for the treatment of primary dementia and PK-MERZ® and PK-LEVO® for Parkinson's disease.