The Effects of BBIC on Multiple Sclerosis

DESCRIPTION: (Adapted from the Applicant's Abstract) The goal of the proposed studies in this SBIR Program is to develop a protease inhibitor-containing product which can be developed commercially as an anti-inflammatory agent to be utilized in the treatment of Multiple Sclerosis (MS). In Phase I, we propose a feasibility study to investigate whether Bowman-Birk Inhibitor Concentrate (BBIC), a drug containing high levels of the Bowman-Birk protease inhibitor (BBI) can affect indicators of neuroinflammatory disease in rats with experimental autoimmune encephalomyelitis (EAE), an animal model of MS. EAE will be induced in rats by immunization with guinea pig myelin basic protein. We propose two experiments. The first will be a pilot study to determine a dose of BBIC which can affect the clinical symptoms of rats with EAE. The second study will be a larger experiment designed to 1) show the effect of BBIC on these symptoms with statistical significance, 2) confirm this effect histopathologically, and 3) attempt to show correlation of these symptoms with serum levels of soluble vascular cell adhesion molecule, a protein marker of inflammation. BBIC will be administered orally in both studies. We plan to move to a pilot human study in Phase II. PROPOSED COMMERCIAL APPLICATION: Should clinical trials indicate a beneficial effect, we plan to market BBIC tablets for use as a therapeutic agent in the treatment of Multiple Sclerosis.