Bayhill Therapeutics Presents Data From a Phase II Trial of BHT-3009 in Multiple Sclerosis at American Academy of Neurology 60th Annual Meeting

PALO ALTO, Calif.--(BUSINESS WIRE)--Apr 16, 2008 - Bayhill Therapeutics, Inc. today announced that the Company's co-founder and Vice President of Research, Hideki Garren, M.D., Ph.D., gave a podium presentation at the American Academy of Neurology 60th Annual Meeting (AAN) in Chicago. Dr. Garren's presentation, "Results from a Phase II Trial of a Myelin Basic Protein Encoding DNA Vaccine for Relapsing Multiple Sclerosis," provides further analysis of data from a Phase II study evaluating BHT-3009, a tolerizing DNA vaccine for multiple sclerosis (MS).

Dr. Garren's presentation focused on findings from all patients enrolled in two of the study's sites, a total of 80 patients from whom cerebral spinal fluid (CSF) was collected at week 0 to define a responder population based on baseline CSF levels of total immunoglobulin (IgG).

Patients whose baseline CSF IgG levels were greater than or equal to 2.5 mg/dl, representing 73% of the 80 patients in the cohort who provided CSF, demonstrated a statistically significant response to 0.5 mg BHT-3009. In this population, the number of new gadolinium (Gd)-enhancing lesions shown on brain magnetic resonance imaging studies (MRIs) from weeks 28 to 48 was reduced by 44% (p=.04) versus placebo. Annualized relapse rates for this group were reduced by 36%.

Patients in the 0.5 mg dose group of BHT-3009 also demonstrated the induction of immune system tolerance. The group dosed with 0.5 mg of BHT-3009 showed statistically significant reductions in autoantibodies targeting six different myelin proteins. These autoantibodies were measured by Bayhill's proprietary microarray technology at weeks 0 and 44. The reduction in autoantibodies targeting multiple myelin proteins indicates that BHT-3009 may produce a broad response in a heterogeneous population of MS patients. The placebo group did not demonstrate significant changes in any autoantibodies.

Commenting on the data from the Phase II study, Dr. Lawrence Steinman, Professor of Neurology and Neurological Sciences at Stanford University School of Medicine and co-founder of Bayhill said, "We are pleased with the results of this study in which we saw not only a strong response to BHT-3009 but also the induction of tolerance. We look forward to confirming both the dose of BHT-3009 and the patient selection criteria we have identified in a Phase IIb study scheduled to commence later this year."

The study enrolled 289 relapsing-remitting MS patients aged 18 to 55 who had suffered at least one relapse in the previous year and whose screening MRI was consistent with MS and showed 0-5 Gd-enhancing lesions. For inclusion, the subjects also needed an Expanded Disability Status Scale rating of less than or equal to 3.5. Patients were randomized 1:1:1 into placebo, 0.5 mg of BHT-3009, or 1.5 mg of BHT-3009, injected intramuscularly at weeks 0, 2, 4, and every 4 weeks thereafter until week 44. The primary endpoint was the 4-week rate of occurrence of new Gd-enhancing lesions on brain MRIs from weeks 28 to 48.

Top-line data for the same study, which demonstrated strong evidence of antigen-specific tolerance produced by BHT-3009, was announced in a separate press release dated October 4, 2007.

About BHT-3009

BHT-3009, an investigational product, is an antigen-specific plasmid encoding myelin basic protein (MBP). Early clinical data suggest that BHT-3009 reprograms the immune system to tolerize to, rather than attack, MBP and other myelin proteins in the myelin sheath of the central nervous system of MS patients. In particular, data from two completed placebo-controlled clinical trials demonstrated BHT-3009's potential to treat relapsing remitting (RR)-MS patients with high levels of immune activity, with a safety profile similar to placebo.

About Multiple Sclerosis (MS)

MS is a chronic autoimmune disease characterized by the immune system's attack on specific self-antigens, such as myelin basic protein (MBP) present in the myelin sheath of the central nervous system. This attack on self-antigens leads to the onset of MS, which is characterized by symptoms of numbness, lack of coordination, blindness and paralysis.

According to an article published in The New England Journal of Medicine in 2006, MS is the most common non-traumatic cause of disability in young adults in the United States and Europe. According to the National Multiple Sclerosis Society (NMSS) an estimated 400,000 people in the United States have MS, while more than two million people are afflicted worldwide.

About Bayhill Therapeutics

Bayhill Therapeutics is a clinical-stage biopharmaceutical company using its proprietary therapeutic BHT-DNA(TM) platform to develop a pipeline of novel and targeted treatment candidates for autoimmune diseases. The Company's product candidates are designed to restore the immune system to its normal state known as "tolerance," by selectively eliminating specific, harmful immune responses while leaving the rest of the immune system intact. The Company has two lead product candidates in the clinic based on BHT-DNA(TM) that the Company believes have demonstrated safety and tolerability, in addition to preliminary efficacy. The first product candidate, BHT-3009, was the subject of a completed Phase II trial for MS. The second product candidate, BHT-3021, is currently in a Phase I/II trial for type 1 diabetes (T1D). More information about Bayhill Therapeutics is available at www.bayhilltx.com

Contact

Bayhill Therapeutics, Inc.
Mark W. Schwartz, Ph.D, 650-320-2800
President/CEO
mwschwartz@bayhilltx.com
Fred Kurland, 650-320-2800
Chief Financial Officer
fkurland@bayhilltx.com
or
The Ruth Group
Sara Ephraim, 646-536-7002 (Investors)
sephraim@theruthgroup.com
Janine McCargo, 646-536-7033 (Media)
jmccargo@theruthgroup.com

Posted: April 2008

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