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
Mark W. Schwartz, Ph.D.
President, CEO, Director
Bayhill Therapeutics Inc.
650-320-2801
mschwartz@bayhilltx.com

or

Fred Kurland
Chief Financial Officer
Bayhill Therapeutics Inc.
650-320-2808
fkurland@bayhilltx.com


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