Results of a clinical trial funded by Bayhill Therapeutics, Inc. shows that BHT-3009, a newly developed DNA vaccine against multiple sclerosis appears safe and may produce beneficial changes in the brains and immune systems of individuals with MS. The data is based on a study of 30 patients with relapsing-remitting MS or secondary progressive MS conducted between 2004 and 2006. The results are published online and will appear in the October 2007 print issue of Archives of Neurology.

"BHT-3009 was safe and well tolerated, provided favorable trends on brain MRI and produced beneficial antigen-specific immune changes," the authors write. These changes included a reduction in the number of cytokine-producing CD4+ T cells (a type of white blood cell) specifically targeting myelin proteins. This reduction was found in the blood as well as in the cerebrospinal fluid of three patients who voluntarily underwent lumbar puncture after completing the course of BHT-3009. "There were no increases in clinical relapses, disability, drug-associated laboratory abnormalities, adverse events or the number and volume of contrast-enhancing [visible on MRI] lesions on brain MRI with BHT-3009 treatment compared with placebo," the authors write. "In fact, there was a trend toward a decrease in the number and volume of contrast-enhancing lesions in the brain in patients treated with BHT-3009 compared with placebo."

A phase 2b trial consisting of approximately 290 patients is already under way.