Accentia Biopharmaceuticals Files for Phase III Revimmune Trial

Accentia Biopharmaceuticals has filed a preliminary investigational new drug application with the FDA for a proposed pivotal Phase III clinical trial of Revimmune in the treatment of refractory multiple sclerosis (MS).

The proposed trial will involved approximately 270 patients with relapsing/remitting MS with a primary endpoint of improvement in function (reversal of disability), Accentia said.

According to the company, no other approved therapy for MS has shown a recovery of neurologic function and all others have been approved on the more limited basis of reducing the risk of disease exacerbation or progression. Its proposal to use the restoration of neurologic function as the endpoint will be the first filed with the FDA, the company added.

Based on a clinical study at the Johns Hopkins University School of Medicine, which showed an unprecedented 42 percent average improvement in function, the company said it believes that Revimmune holds the potential to restore function in many patients who have acute deficits due to MS.

The company added that it believes the long-term follow-up with patients in the proposed 48-week trial will demonstrate that Revimmune induces not only a reduction of the risk of exacerbations, but potentially also long-lasting remissions and/or cures in MS patients.