Accentia Biopharmaceuticals has filed a preliminary Investigational New Drug application with the FDA for Revimmune in the treatment of refractory multiple sclerosis.

The company has requested a meeting with the FDA within the next 60 days to discuss a proposed pivotal Phase III clinical trial involving approximately 270 patients with relapsing/remitting multiple sclerosis (MS) with a primary endpoint of improvement in function (reversal of disability).

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

In addition, the company believes that 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 possibly cures in MS patients.

Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. Investigators at Johns Hopkins discovered that stem cells uniquely have high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to a new immune system over two to three weeks.

The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.

Source: Pharmaceutial Business Review ©2007 Business Review (01/08/07)