Bayhill Therapeutics to Present Phase II Follow-up Data on BHT-3009 for Treatment of Multiple Sclerosis

Abstract Accepted for 61st Annual American Academy of Neurology (AAN) Meeting

Survey Protocol Data Demonstrate Reduction in Relapse Rates and Decreases in Brain Lesions

SAN MATEO, Calif.--(BUSINESS WIRE)--Mar 9, 2009 - <!-- cpurl -->Bayhill Therapeutics<!-- /cpurl --> Inc., a clinical-stage biopharmaceutical company leveraging its proprietary BHT-DNA™ platform to develop novel and targeted autoimmune disease treatments, today announced that an abstract titled “One Year Follow-up Results from a Phase II Trial of the BHT-3009 DNA Vaccine for Multiple Sclerosis,” has been accepted for presentation at the 61st Annual American Academy of Neurology (AAN) meeting, to be held in Seattle, Washington from April 25 through May 2, 2009.

Data in the abstract indicates that BHT-3009 has a durable effect and continues to have a favorable safety profile for up to 12 months following the completion of dosing. BHT-3009 is an antigen-specific plasmid encoding myelin basic protein (MBP) that aims to reprogram the immune system to tolerize to, rather than attack, myelin antigens in the central nervous systems of multiple sclerosis (MS) patients.

In August 2008, Bayhill completed the 12-month follow-up phase (Survey Protocol) of a Phase II clinical trial of <!-- ppurl -->BHT-3009<!-- /ppurl --> in relapsing-remitting MS (RR-MS) patients. The Survey Protocol data demonstrated a decrease in relapse rates and a corresponding continued reduction in magnetic resonance imaging (MRI) gadolinium enhancing (Gd+) lesion activity. The Survey Protocol data builds on results previously published in Annals of Neurology (63(5):611-20, 2008), which demonstrated a reduction in MRI Gd+ lesions during the 44-week treatment period. Key updated results for the Survey Protocol are as follows:


  • Relapse data: The annualized relapse rate (ARR) decreased during the first six months of the Survey Protocol (0.16 and 0.37 relapses per year in the 0.5 mg and the 1.5 mg dose cohorts, respectively). The ARR and the proportion of relapse-free patients over the full 12-month Survey Protocol was comparable to recently published studies from both approved MS therapies and compounds in late stage clinical development.
     
  • MRI parameters: Consistent with ARR reduction, a decrease in total brain Gd+ lesions was maintained seven months after the last dose of BHT-3009, with an improvement in the number Gd+ lesion-free patients and a reduction in the mean number of Gd+ lesions for all patients.
     
  • Safety: BHT-3009 continued to demonstrate an excellent safety profile 13 months after the last dose of BHT-3009, with reported safety data similar to the safety data reported during the 44-week treatment phase. There were no treatment related serious adverse events, and greater than 95% of all adverse events were mild to moderate.
     

Mark W. Schwartz, PhD, CEO and President of Bayhill Therapeutics, commented, “We are pleased to report that Survey Protocol data on BHT-3009 demonstrate continued improvement in both MRI and relapse rates in patients with RR-MS. These data support the design and execution of a Phase IIb clinical trial of BHT-3009 targeting the overall RR-MS patient population, in preparation for Phase III studies. We are currently in discussions with potential partners to support the next stage of development for BHT-3009, and we are confident that our completed data in RR-MS patients makes BHT-3009 an attractive opportunity for pharmaceutical and biotechnology companies looking for a groundbreaking first-line approach towards the treatment of MS.”

ABOUT THE TRIAL

Two hundred and eighty nine patients with relapsing-remitting MS (RR-MS) were initially randomized to receive intramuscular (IM) injections of either BHT-3009 (0.5 mg or 1.5 mg) or placebo for 44 weeks (treatment period). Of these patients, 95 out of 96 patients originally treated with 0.5 mg and 83 out of 84 patients originally treated with 1.5 mg of BHT-3009 participated in the 12-month follow-up phase (Survey Protocol). The primary objective of the Survey Protocol was to evaluate safety after 44 weeks of treatment with BHT-3009, and secondary objectives included examination of gadolinium (Gd+) enhancing lesions by brain magnetic resonance imaging (MRI) as well as clinical relapse activity.

About BHT-3009

BHT-3009 is an antigen-specific plasmid encoding myelin basic protein (MBP) currently being evaluated for the treatment of multiple sclerosis (MS). Clinical results to date suggest that BHT-3009 reprograms the immune system to tolerize to, rather than attack, the myelin antigens in the central nervous system of MS patients. Designed to treat MS in a specific and targeted manner, BHT-3009 has the potential to effectively treat MS with fewer side effects and a superior administration profile compared to currently available MS therapies.

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 myelin self-antigens leads to the onset of MS, 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 at the forefront of developing novel and targeted treatment candidates for autoimmune diseases. Leveraging its proprietary therapeutic BHT-DNA™ platform, the Company's product candidates have been 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. Through a targeted and selective approach, Bayhill's product candidates have the potential to deliver superior efficacy, safety and tolerability relative to current therapies.

Bayhill is in active discussions with potential pharmaceutical partners for the further advancement of two BHT-DNA™-based disease modifying product candidates that have demonstrated safety, tolerability, and preliminary efficacy in patients: BHT-3009, a treatment candidate poised to enter a Phase IIb clinical study in patients with multiple sclerosis (MS); and <!-- ppurl -->BHT-3021<!-- /ppurl -->, an investigational treatment for type 1 diabetes (T1D) currently being evaluated in an ongoing Phase I/II clinical study. For more information please visit www.bayhilltherapeutics.com/

Contact: Bayhill Therapeutics, Inc.
Mark W. Schwartz, PhD, 650-320-2800
CEO and President
mwschwartz@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: March 2009

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