Results were released recently from a study of a medication that may promote myelin repair. The MS Center at Swedish was one of the research sites for this study. The medication, rHIgM22, is an antibody that encouraged myelin repair in animal models. The way that it helps with myelin repair is not known. This study was a phase I study, which means that it was the first time that this medication was used in humans. Phase I studies are done to determine the safety of a medication, and also to help determine the dose of the medication.
In this study, patients received either the real drug or a placebo. The study was conducted on five groups of patients, with ten patients in each group. In each group, eight received the real medication and two received placebo. The first group of patients received the lowest dose of medication. With each new group of patients the dose was increased. The results of the study found that all five doses were very well tolerated with minimal side effects. There were no serious side effects and even the highest dose was well tolerated. This study was not designed to determine whether the medication actually promoted myelin repair.
The next step for this medication will be to plan a phase II study, followed by a phase III study after that. Phase II studies are used to further investigate the safety of a medication, and to look at how the medication might perform on various outcome measurements. The best of these measurements are then taken forward to the phase III study that will determine if the medication is successful in repairing myelin.
It is exciting to know that medications are now being studied that we hope will help repair myelin and the damage that MS creates. There are several strategies being studied in addition to rHIgM22. These include mesenchymal stem cells and various chemical signals that our bodies use to direct the growth of myelin. The MS Center has been involved in four of these studies thus far. We look forward to seeing these studies continue with the hope that we may one day be able to repair the damage caused by MS.
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