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A Phase I/II Randomized, Blinded, Placebo Controlled, Safety and Pharmacodynamic Study of BHT-3021 with Open Label Cross-Over in Subjects with Type 1 Diabetes Mellitus

BHT-3021 is an investigational drug based on the BHT-DNA antigen-specific immuno-modulatory platform.  The goal of this investigational drug is to reduce or eliminate the immune system’s attack on the pancreas, thereby shutting down the disease process which gives rise to type 1 diabetes.  Initial trial results of BHT-3009, another investigational drug based on the BHT-DNA platform but targeting multiple sclerosis, were recently published in Archives of Neurology (Arch Neurol, Oct 2007; 64: 1407 - 1415), and results of the phase II study were recently presented at ECTRIMS (ECTRIMS Presentation title: Phase 2b Trial of a MBP-Encoding DNA Plasmid (BHT-3009) for the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). Abstract 48)

This is a multi-center, randomized, blinded, placebo-controlled cross over phase I/II trial in subjects
with type 1 (autoimmune) diabetes (T1D). 


To receive more information and find out if you are qualified, please contact one the trial sites listed below directly:

Peter Gottlieb, MD
Barbara Davis Center
Aurora, Colorado
Study contact: Lisa Meyers
Phone: 303-724-6893
Fax: 303-724-6706
Lisa.Meyers@uchsc.edu

Mark Kipnes, MD
Diabetes and Glandular Disease Clinic
San Antonio, Texas
Study contact: Ben Blaylock, RN
Phone 210-615-5565
Fax: 210-614-8093
bblaylock@dgdresearch.com

Robert Ratner, MD
Medstar Research Institute
Washington, D.C.
Phone 202-787-5373
Fax: 202-787-5324


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.


CONTACT
Bayhill Therapeutics Inc.
650-320-2800