Bayhill Therapeutics, Inc, a leading developer of therapies for autoimmune diseases, and the Juvenile Diabetes Research Foundation (JDRF), the world's leading charitable funder of type-1 diabetes research, announced a partnership to support Bayhill's ongoing phase-I/II human clinical trial of BHT-3021, a DNA vaccine to reverse the immune response that causes type-1 diabetes.

BHT-3021 is an antigen-specific immunotherapeutic DNA vaccine designed to reverse the underlying autoimmune disease process in diabetes, and slow down or halt further loss of pancreatic beta cell function.

"We are very pleased to have the support of JDRF as we advance the clinical development of BHT-3021," said Mark W Schwartz, Bayhill's president and CEO. "This agreement demonstrates JDRF's commitment to funding ground-breaking clinical research and to the development of novel therapeutics that can potentially have an important impact on the lives of people with diabetes. There are currently no disease-modifying products available to the millions of patients suffering from this disease. We believe BHT-3021 will provide a better treatment alternative for them."

JDRF funds diabetes research across a range of scientific areas, including beta cell regeneration, immunology, islet cell replacement, complications, genetics, and technological innovations and therapeutics to improve metabolic control. The agreement with Bayhill is a part of JDRF's innovative Industry Discovery and Development Partnership programme, through which JDRF partners with pharmaceutical, biotech, and medical device businesses looking to develop drugs, treatments, technologies, and other therapeutics leading to a cure, reversal, or prevention of type-1 diabetes and its complications. Through its IDDP Programme, JDRF will provide up to $3 million toward the phase-I/II clinical trial. Funding will be based on Bayhill attaining specific clinical milestones expected to be reached by the third quarter of 2009.

Through its IDDP programme, JDRF has funded some 25 companies, representing approximately $29 million in diabetes science.

"Our partnership with Bayhill Therapeutics reflects JDRF's commitment to accelerating the pace of science leading to a cure for type-1 diabetes," said Dr Richard A Insel, JDRF executive vice president, Research. "Bayhill's DNA vaccine protocol has the potential to negate the autoimmune process causing type-1 diabetes, which must be addressed to cure the disease."

BHT-3021 is a plasmid encoding proinsulin designed to tolerize the immune system, thereby turning off the self directed immune attack against the islet cells.

Bayhill Therapeutics is a clinical-stage biopharmaceutical company using its proprietary therapeutic BHT-DNATM platform to develop a pipeline of novel and targeted treatment candidates for autoimmune diseases.

About JDRF
JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder and advocate of type-1 research.