BHT-3009 Meeting/Info Results

A board to discuss future MS therapies in early stage (Phase I or II) trials.

BHT-3009 Meeting/Info Results

Postby Dunmann » Tue Apr 04, 2006 9:43 am

There's some great info about the drug below.


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
4/4/2006 8:41:00 AM EST

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

CONTACT:

Bayhill Therapeutics Inc. Mark W. Schwartz, Ph.D., 650-320-2801 (President, CEO) mwschwartz@bayhilltx.com www.bayhilltx.com Lorraine Ruff, 206-444-0022 (Corporate Communications) lorraine@thinkmilestones.com
Dunmann.
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