Relapsing-remitting MS is marked by periodic increases in brain inflammation and disease symptoms, interspersed with periods of full or partial recovery. Previous research suggested that introducing an altered form of MBP into MS patients might cause the body to react to the normal MBP in a protective way instead of a harmful way, thereby stopping flare-ups of the disease. After studying the patients' normal disease patterns for 6 months, the researchers administered 50 mg of APL weekly for up to 9 months while using clinical tests, immunology work-ups, and MRI scans to carefully monitor the effects of the therapy in patients. Two out of eight treated patients showed an increase in inflammatory brain lesions that was linked to the APL therapy by sophisticated studies of their immune cells. One patient developed a general hypersensitivity reaction and three others discontinued dosing due to side effects that could not be directly linked to the therapy.
Hypersensitivity is a condition in which the body over-reacts to a protein or other stimulus.
After the first seven patients showed adverse effects, the dose was reduced to 5 mg for the eighth patient. When this patient also showed an increase in MS lesions that appeared to be related to the therapy, the trial was halted prematurely. In the second study, Ludwig Kappos, M.D., of the University of Basel, Switzerland, Lawrence Steinman, M.D., of Stanford University Medical School, and collaborators at 14 research centers in the United States, Europe, and Canada conducted a randomized, double-blind clinical trial designed to test the therapy in 144 patients. The study was sponsored by Neurocrine Biosciences, Inc., and by Novartis. Patients were then offered the therapy at a dose of 5 mg weekly.