Bayhill Therapeutics, Inc. Research on Multiple Sclerosis Chosen As One of the Meeting's Scientific Program Highlights at the 58th Annual Meeting of the American Academy of Neurology
Posted on: Tuesday, 4 April 2006, 09:01 CDT
Bayhill Therapeutics will make two presentations today at the 58th Annual Meeting of the American Academy of Neurology in San Diego in connection with development of the company's lead drug candidate, BHT-3009, for the treatment of multiple sclerosis.
-- 2:30 PM, abstract #S02.003:
http://www.bayhilltx.com/AAN_2006_abstract_S02_003.pdf
-- 2:45 PM, abstract #S02.004: http://www.bayhilltx.com/AAN_2006_abstract_S02_004.pdf NOTE: The S02.004 abstract has been selected by the AAN's Scientific Program Subcommittee and the Science Committee as one of the meeting's scientific program highlights (top 5 percent) for inclusion in the "Scientific Program Highlights Plenary Session" on Friday evening, April 7, from 5:15-6:15 PM. For more information about this acknowledgement by the Scientific Program, contact Kevin Heinz at kheinz@aan.com, or (651) 695-2773. RESEARCH/PROGRAM HIGHLIGHTS 1. First in man trial of a DNA plasmid therapeutic for multiple sclerosis (MS), an autoimmune disease. 2. BHT-3009 is an antigen-specific treatment for MS and has been specifically designed to NOT cause broad-based immunosuppression, or adverse events. 3. BHT-3009 expresses full-length human MBP, the major target of the autoimmune response in the majority of MS patients. 4. Distinguished from other antigen-specific approaches attempted in the clinic, the DNA allows low-level persistence of the antigen for 2-4 weeks. BHT-3009 has been engineered to tolerize the patient's immune system by targeting the entire MBP (the protein that causes multiple sclerosis) molecule rather than only a small portion of it. Phase I/II trial results: 5. BHT-3009 is safe; adverse events actually higher in the placebo arm. 6. Brain MRI shows trends toward improvement in Gad + lesion count with BHT-3009 versus placebo. In a MRI procedure, Gad highlights active lesions as opposed to quiescent lesions. 7. All patients are clinically stable with treatment. 8. Peripheral T cell assays showed decrease in activity of MBP specific T cells in a number of patients. 9. Safety and proof-of-concept has been demonstrated in this phase I/II 30 patient trial. Phase IIb trial: 10. Enrollment in this double-blind, placebo-controlled, multi-center trial has begun. 11. A total of 252 patients being recruited throughout both Eastern and Western Europe and the United States. 12. Dosing will be for one-year with MRI Gad + lesion formation as the primary endpoint. NOTE: BHT-3009 is NOT "gene therapy" because it does not integrate into the genome.
Background resources
MS overview: http://www.bayhilltherapeutics.com/ms.html
Other scientific research findings: http://www.bayhilltherapeutics.com/publications.html
Bayhill Therapeutics web site: http://www.bayhilltx.com
Source: Business Wire
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