MONDAY, Aug. 13 (HealthDay News) -- BHT-3009, a DNA vaccine that encodes full-length human myelin basic protein, appeared to be safe and reduced myelin specific autoantibodies in cerebrospinal fluid in a phase I/II trial of multiple sclerosis patients. The results are published in the Aug. 13 issue of the Archives of Neurology.
Hideki Garren, M.D., Ph.D., of Stanford University in Stanford, Calif., and colleagues conducted a randomized, double-blind, placebo-controlled trial of 30 patients with relapsing-remitting or secondary progressive multiple sclerosis who also had one to five gadolinium-enhancing lesions as seen on a magnetic resonance imaging scan, a relapse within the previous two years or a worsening of their condition over the same period.
The trial tested BHT-3009 in three doses -- 0.5 mg, 1.5 mg and 3 mg -- which were administered as intramuscular injections at weeks one, three, five and nine, on its own, or in combination with 80 mg a day of oral atorvastatin. The vaccine was well-tolerated and produced encouraging antigen-specific immune changes. In addition, there were encouraging trends in regards to brain lesions evident on magnetic resonance imaging. The vaccine is now in a phase IIb trial.
"If successful in multiple sclerosis, antigen-specific DNA vaccines can be developed for prevention or treatment of related diseases, such as type 1 diabetes mellitus, systemic lupus erythematosus, rheumatoid arthritis and myasthenia gravis," the authors conclude.
The study was funded by Bayhill Therapeutics, Inc.
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