Multiple Sclerosis - Moses Rodriguez

Update: Towards a Remyelination Clinical Trial

It is a pleasure to present to you a progress report in 2009 regarding our steps to bring recombinant antibody 22 (rHIgM22) to a clinical trial to enhance remyelination. As many of you know, we have identified a monoclonal antibody from humans that appears to induce myelin repair in a number of animal models of multiple sclerosis. We are very anxious to get this antibody into a clinical trial.

The first series of human experiments will be a Phase I clinical trial in which we will look primarily at safety and establish the appropriate dose to give patients. Prior to beginning the clinical studies, however, investigators must first accomplish a number of goals. First, we have to generate large quantities of pure recombinant antibody that is acceptable to the FDA. Second, we must process the antibody to greater than 99% purity. Then the antibody needs to be tested to screen for possible toxic effects in humans.

I am happy to report that we have already completed a number of these steps. We have already generated large quantities of the antibody. A final production run of the antibodies for use in animal studies and then clinical studies is beginning. Secondly, we have developed all the methodologies to purify the antibody to the specifications required by the FDA and to assure ourselves that no adventitial viruses or bacteria or other sources of DNA are contaminating the process. We have also completed some toxicity experiments. Thus far, no serious toxicity has been found.

Once the toxicity studies are finished, we have to write an IND (investigational new drug) application. This document is submitted to the FDA. The FDA has 30 days to respond with criticisms. If the FDA does not respond, we can then begin the clinical trials.

We do not know exactly when the clinical trials will begin. It will depend on the length of toxicity tests and our ability to manufacture the final batch of the antibody.

Acorda Pharmaceuticals has shown a significant interest in the antibodies and is helping to fund part of the primate experiments. We are also indebted to the Hilton Foundation, which has renewed our grant to take this antibody to clinical trial. The grant has been renewed for another three years to provide the funds to carry out the clinical experiments.

We are encouraged by the progress made thus far in getting this antibody into clinical trial, and we hope it will soon enter Phase I clinical trial in humans to determine if the antibody is safe and, hopefully, efficacious.