Phase I Trial of Immunotherapy with BHT-3009 Alone or Combined with Atorvastatin in Patients with Multiple Sclerosis
Location: Four centers in the US and Canada
Purpose: To assess the safety of BHT-3009 alone or combined with atorvastatin (Lipitor®) in patients with multiple sclerosis (MS), and to determine the effect of treatment on immune response.
Eligibility:
• Men and women, at least 18 years old
• Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
• Gd+ lesions on MRI, or relapse within last 2 years, or disease worsening in last 2 years
• Off interferon and other treatments for at least 1 month.
Procedure: Participants will receive an injection of BHT-3009 four times in 8 weeks (Weeks 1, 3, 5, 9), and atorvastatin daily during the treatment/assessment period (13 weeks). They will be assessed for safety (MRI, neurostatus exam, blood work, etc.) and blood will be drawn to test for immunological responses. Patients who receive placebo in the first 13 weeks, will receive active treatment in the next 13 weeks, so ALL patients will receive active treatment.
Benefit: May lead to an improved treatment for MS.
For Information: Visit www.bayhill therapeutics. com/pt_info.html or contact the study sites listed below.
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Arizona
Barrow Neurology Clinics
Phoenix, Arizona, 85013, USA
Colleen Sweeney, MA, CCRC 602-406-6291
Timothy Vollmer, MD, Principal Investigator
California
USC, LAC & USC Medical Center
Los Angeles, CA, 90033, USA;
Patricia Rourke 323-224-5332
Pat Gutierrez 323-224-5333
Leslie Weiner, MD, Principal Investigator
Canada, British Columbia
University of British Columbia, MS Research
Vancouver, BC, V6T 2B5, Canada
Wendy Morrison, RN, MSCN 604-822-7511
Joel Oger, MD, Principal Investigator
Canada, Quebec
Montreal Neurological Institute, Clinical
Research Unit and MS clinic
Montreal, Quebec, H3A 2B4, Canada
Sherene Guindi 514-398-6052
Yves Lapierre, MD, Principal Investigator
Study chairs or principal investigators
Frank Valone, MD, Study Director,
Bayhill Therapeutics