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Investigators in France are recruiting up to 53 people with secondary-progressive MS for a study comparing PI-2301 (Peptimmune, Inc.) with inactive placebo. Secondary-progressive MS starts with a relapsing-remitting course and then transitions to a steadily worsening disease course with or without occasional flare-ups. The study is sponsored by Peptimmune, and the primary investigator is Gilles Edan, MD (CHU Rennes, France).
PI-2301 is a drug delivered once weekly subcutaneously (under the skin). It is a copolymer (similar to Copaxone® [Teva Pharmaceutical Industries Ltd.], a drug approved to treat MS), a protein fragment that affects immune “T cells” which attack the brain and spinal cord in MS. In a small, phase 1 study of 56 people without MS, eight doses were safe and well tolerated, and there were no serious adverse events. This study was reported in a press release from Peptimmune on March 18, 2008. The current study is the first in people with MS.
People between the ages of 18 and 60 are eligible for this study. Patients must have had a diagnosis of secondary-progressive MS for 1-10 years.
Participants will be randomly assigned to one of four groups. Within each group, they will be randomly assigned to receive the study drug or inactive placebo subcutaneously for eight weeks. After eight weeks, all participants will receive the study drug. The primary goal of the study is to determine the safety and tolerability of the four dose levels. Secondary objectives are to evaluate MRI scans, EDSS (a scale used to measure MS disease activity), and immunological markers.
Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
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