DNA Vaccine for MS Passes Phase I

A new DNA vaccine made by Bayhill Therapeutics (Palo Alto, CA, www.bayhilltherapeutics.com/ms.html), has passed a Phase I trial in patients with multiple sclerosis (MS) and is set to enter the next development stage.

The drug, BHT-3009, is an investigational immunotherapy product designed to alter the immune response to myelin basic protein (MBP). Patients with the disease are thought to have an immune response that attacks certain proteins in the brain, including MBP. BTH-3009 is the first DNA-based vaccine for MS to be tested in humans.

The Phase I trial was conducted between 2004 and 2006 in 30 patients with relapsing-remitting MS. The main goal of the study was to test the safety of the vaccine, the first to be given to humans to treat an autoimmune disease such as MS.

The researchers said they "demonstrated that BHT-3009 is safe and well tolerated," in an article to be published in the October print issue of Archives of Neurology, one of the JAMA and Archives journals. Patient enrolment has now started for a 12-month Phase IIb trial of BHT-3009, expected to test 290 participants.