Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune
system attacks and destroys the cells that cover and protect nerves. This study will test
the safety of a new drug called RG2077 that is designed to treat MS. The study will not
determine whether RG2077 is effective in treating MS, only whether it is safe to use in
patients with MS.
Study hypothesis: RG2077 will arrest MS if administered early in the course of MS and
decrease accumulation of lesions on MRI.
Effective treatment of autoimmune disorders is likely to arise not from improved
immunosuppression, but from improved understanding of the normal mechanisms that generate
and maintain self-tolerance. RG2077 may block a T cell costimulation pathway central to the
pathophysiology of MS. A total of 20 patients with MS will be enrolled in this study. Each
patient participates in the study for 4 months.
The dose-escalation portion of this study evaluated the safety of a single infusion of
RG2077 (CTLA4-IgG4m) in 16 patients with MS and is now complete. Patients who participated
in the single infusion portion of the study were assigned to one of four groups. Each group
received a different dose of RG2077. The second portion of the study will evaluate the
safety of 4 doses of RG2077 in 4 additional patients. In the multiple infusion portion of
the study, all patients will receive the same dose of RG2077. Patients will be monitored for
possible side effects of RG2077.
- Confirmed diagnosis of MS, defined as an MRI consistent with MS plus two separate
clinical events, or one clinical event and MRI consistent with demyelination plus a
second MRI demonstrating new lesions
- Have declined all FDA approved therapies for MS