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.

SAN DIEGO -- 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 [e-mail], or [phone].


    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