- This DNA vaccine to myelin basic protein (MBP) contains the gene for MBP and is administered by intramuscular injection. This therapy is designed to cause immune tolerance, by reprogramming the immune system to modulate the response of the antigen-specific 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 recent study indicated that a decrease in total brain lesions was maintained seven months after the last dose, with an improvement in the number of lesion-free patients and a reduction in the average number of lesions for all patients. No treatment-related serious adverse events occurred, and more than 95 percent of all adverse events were mild to moderate. Survey protocol data on BHT-3009 demonstrate continued improvement in both MRI findings and relapse rates in patients with RRMS. Bayhill is currently discussing Phase III studies with potential partners.