The company said its test drug is unique in the MS market because it is the first treatment aimed at restoring neurologic function in patients with the disease, and at eliminating the autoimmune response that causes the debilitating disorder of the central nervous system.

Accentia said it has requested to meet within the next 60 days with officials from the Food and Drug Administration to discuss the proposed study involving about 270 patients with relapsing/remitting MS.

The study's primary endpoint will be improvement in neurologic function.

Current therapies for MS are designed to reduce the risk of disease progression, but not to reverse the disability that marks the disease, Accentia said.

A previous study of Revimmune done at the Johns Hopkins University School of Medicine showed an unprecedented 42-percent average improvement in function, the company said.

Accentia said the investigational drug "holds the potential to restore function in many patients who have acute deficits due to MS" and that long-term follow-up of patients enrolled in the 48-week, phase 3 study might even show "long-lasting remissions and/or cures" in MS patients.