This research study is being done to evaluate the safety of BHT-3009 alone and when combined with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).
This research study is being done to evaluate the safety of BHT-3009 alone and when combined with atorvastatin (Lipitor) in patients with multiple sclerosis (MS). Patients with MS are thought to have an immune response that attacks certain proteins in the brain, including myelin basic protein. (Myelin basic protein is a protein that makes up part of the outside layer of nerve cells.) BHT-3009 is an investigational immunotherapy product that is designed to alter the immune response to myelin basic protein and make the response less harmful. BHT-3009 contains the DNA (gene) for myelin basic protein. Three different doses of BHT-3009 will be tested to determine if there are any differences in safety or effects on immunity. This is the first clinical research study of BHT-3009. Laboratory studies have shown that BHT-3009 and atorvastatin given together alters the immune response to myelin basic protein and makes the response less harmful.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Barrow Neurology Clinics
Phoenix, Arizona, United States
USC, LAC & USC Medical Center
Los Angeles, California, United States
University of British Columbia, MS Research
Vancouver, British Columbia, Canada
Montreal Neurological Institute, Clinical Research Unit and MS clinic
Montreal, Quebec, Canada
Evaluate safety of BHT-3009 alone and when combined with atorvastatin in patients with multiple sclerosis.
Determine dose of BHT-3009 and regimen for phase II testing.
Describe effect of treatment on antibody and T cell responses to myelin basic protein (MBP).
Describe clinical course of treated patients.
Explore biomarkers of MS activity
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