Scientists demonstrate investigational MS drug down regulates the underlying cause believed responsible for multiple sclerosis at the 16th Meeting of the European Neurological Society

DATE OF EVENT: 30 May, 2006

PLACE: Lausanne, Switzerland

WHO/WHAT/WHERE:

Bayhill Therapeutics, a Palo Alto, CA-based biotechnology drug development company, will present clinical findings today at the Sixteenth Meeting of the European Neurological Society 27 May – 31 May, 2006, in Lausanne, Switzerland in connection with development of the company’s lead drug candidate, BHT-3009, for the treatment of multiple sclerosis.

Co-founder and Vice President of Research, Hideki Garren, MD, PhD, will present clinical data for Bayhill’s Phase I/II trial of BHT-3009, and details on the Phase IIb trial of BHT-3009, which is currently being enrolled in Europe. Dr. Garren will make his presentation as follows:

MULTIPLE SCLEROSIS 4 SESSION:
Tuesday, 30 May 2006, 16:15 - 16:30

Phase I/II trial of a MBP encoding DNA plasmid (BHT-3009) alone or combined with atorvastatin for treatment of multiple sclerosis

ROOM: Lausanne, Oral session, 14

ENS ABSTRACT AVAILABLE AT: http://bayhilltx.com/bayhill_ens_2006_abstract.pdf

CONFERENCE INFORMATION: http://www.akm.ch/ens2006/

SPECIAL RECOGNITION: Bayhill’s abstract has been judged by The Scientific Programme Committee to be among the “top 5 percent of those submitted” and will be highlighted at the conference as "Best of Free Communications" on Wednesday, 31 May, 2006, 12:30 – 13:30.

RESEARCH/PROGRAM HIGHLIGHTS:

• Bayhill’s Phase I/II clinical investigation of BHT-3009 is believed to be the first human trial of an antigen-specific DNA plasmid for multiple sclerosis (MS), an autoimmune disease.  
• BHT-3009 is an antigen-specific treatment for MS. The MS therapeutic has been designed to NOT cause broad-based immunosuppression.
• Bayhill’s experimental MS therapeutic, BHT-3009, has been designed to down-regulate rogue T cells specific for MBP. Left unchecked, these rogue T cells shred the myelin sheath that insulates the nerve cells of the brain and spinal cord, resulting in MS. BHT-3009 down regulates, or tolerizes, these MBP specific T cells and only these T cells. The remainder of the immune system remains intact to fight infections and cancer. 
• Researchers and clinicians believe that BHT-3009 is distinguished from other antigen-specific approaches attempted in the clinic in several ways: (1) the DNA allows low-level persistence of the antigen for 2-4 weeks, thus allowing for less frequent dosing.  (2) BHT-3009 expresses full-length MBP, thereby encompassing all possible target auto-antigens rather than a single auto-antigen, and allowing for a broader possible population of responders to the drug.
• Bayhill’s Phase I/II clinical trial of BHT-3009 is complete. In the Phase I/II trial, clinicians observed that BHT-3009 is safe and reported that “adverse events” were higher in the placebo arm compared to the treated arms.
• Clinicians observed brain MRI trending toward improvement in Gad + lesion count with BHT-3009 versus placebo.
• All patients are clinically stable, or improved with treatment.
• Peripheral T cell assays showing decrease in activity of MBP specific T cells were observed in a number of patients.
• Thus, safety and proof-of-concept were demonstrated in this phase I/II 30-patient trial.

Phase IIb trial:

• Enrollment in this double-blind, placebo-controlled, multi-center trial has begun.
• A total of 252 patients are being recruited in the following countries: Bulgaria, Czech Republic, Finland, Poland, Romania, Russia, Serbia, Slovakia, Turkey, Ukraine, UK, and in the US.
• Over 120 patients have been enrolled and randomize to the study as of 30 May 2006.
• Dosing will be for one-year with MRI Gad + lesion formation as the primary endpoint.

For clinical trial enrollment information, please send an email to: BHT3009@bayhilltx.com


Background resources:
MS overview: http://www.bayhilltx.com/ms.html
Other scientific research findings: http://www.bayhilltx.com/publications.html
Bayhill Therapeutics web site: http://www.bayhilltx.com


About Bayhill Therapeutics
Bayhill Therapeutics Inc. is a clinical-stage biotechnology company focused on developing and commercializing therapeutics that fundamentally alter the way autoimmune diseases are treated. The company has developed two therapeutic platforms with broad applicability to a range of autoimmune diseases. Bayhill’s BHT-DNA autoimmune vaccine is designed to eliminate disease-causing cells without affecting normal protective immune system cells. BHT-DNA is being studied in a recently completed Phase II trial for multiple sclerosis and a Phase I/II trial for autoimmune diabetes. Bayhill’s second therapeutic platform is an oligonucleotide; the first product candidate is in preclinical development for systemic lupus erythematosus.

More information about Bayhill Therapeutics is available at www.bayhilltx.com.


CONTACTS
Bayhill Therapeutics Inc.
650-320-2800

or

CORPORATE COMMUNICATIONS CONTACT
Lorraine Ruff
206-444-0022 office
lorraine@thinkmilestones.com