Intrathecal and Subcutaneous BDNF not shown effective in ALS

"On January 23,2001 Regeneron Pharmaceuticals, Inc., was informed by the Chairman of the Data and Safety Monitoring Board that Protocol A-9804, "A Prospective, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Recombinant-Methionyl Human Brain-Derived Neurotrophic Factor (r-metHuBDNF) in Patients with Amyotrophic Lateral Sclerosis (ALS)", being conducted under BB IND # 5188, could not meet its primary endpoint of demonstrating an improvement in survival or the use of continuous mechanical ventilation, and thus recommended that the study be terminated. "A parallel analysis of the results of the trial of intrathecally delivered BDNF also failed to reveal any evidence of efficacy.

"Amgen-Regeneron Partners will terminate the study as rapidly as possible. We are notifying our investigators individually to have the patients remaining on study return to clinic for a final study visit and to return their supplies of study drug. Treatment of patients remaining in the A-9802 study, the ongoing investigator IND study, and the open-label intrathecal study will be terminated as well. "We know this news will come as a great disappointment to all ALS patients. We would especially like to thank all those patients and their families and caregivers who have participated in the BDNF clinical trials in the hopes of helping medical science find a treatment for this dread disease. We are sorry that BDNF failed to fulfill that promise"

Benjamin Rix Brooks, MD Professor of Neurology Director, ALS Clinical Research Center University of Wisconsin Hospital & Clinics
600 Highland Avenue CSC H6-563
Madison, WI 53792-5132 USA
Tel: 608-263-9558
Email: brooks@neurology.wisc.edu

Staff Neurologist and Director, ALS & MS Clinics William S Middleton Memorial VA Medical Center [607] Great Lakes VA Health Care System [VISN 12] 2500 Overlook Terrace, B-6112 Madison, WI 53705-2286 USA
Tel: 608-280-7057 Neurology Office Direct Fax: 608-280-7140
Email: brooks@neurology.wisc.edu

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