This DNA vaccine to myelin basic protein (MBP) contains the gene for MBP. This therapy is designed to cause immune tolerance, by reprogramming the immune system to decrease the response of the immune cells involved with MS. This would reduce the attack against the MBP in the myelin sheath.
Studies to date indicate that this vaccine is safe and well tolerated. BHT-3009 continued to demonstrate an excellent safety profile 13 months after the last dose, and reported safety data is similar to that found during the 44-week treatment phase. A sub-study with BHT-3009 found that pre-treatment levels of anti-MBP antibodies predicted response to treatment with this agent on MRI outcomes of chronic “black hole” lesion formation.36 This suggests a possible biomarker for patients who may respond to this modality of treatment. Bayhill is currently discussing Phase III studies with potential partners.