SBIR-STTR Award

The ultimate goal of the proposed studies is to establish Bowman-Birk Inhibitor Concentrate (BBIC) as an anti-inflammatory agent. This SBIR/Phase 1 grant proposal has two goals. The first is to establish that Bowman Birk Inhibitor Concentrate (BBIC) can be used as an effective anti-inflammatory agent for the treatment of ulcerative colitis (UC), an inflammatory bowel disease. UC will be chemically induced in mice by adding 5% dextran sulfate sodium to the drinking water. The diet of some experimental groups will be supplemented with BBIC, and the effects of BBIC on histopathological alterations occurring in UC measured. The second goal of this proposal is to establish biological and biochemical assays to predict the efficacy of BBIC during the manufacturing of the product for use as an anti-inflammatory agent. Chymotrypsin inhibitory activity will be used for the biochemical parameter, and lipid peroxidation inhibition for the biological parameter. PROPOSED COMMERCIAL APPLICATION: A protease inhibitor derived from soybeans, called the Bowman-Birk inhibitor (BBI) will be evaluated as an anti-inflammatory agent in this SBIR grant proposal. An extract of soybeans enriched in BBI called BBI concentrate (BBIC) will be used in these experiments, and ulcerative colitis, an inflammatory bowel disease, will be used as an in vivo model of inflammation. The aim of this program is to bring BBIC to market as an anti-inflammatory drug to be used in the treatment of ulcerative colitis and other inflammatory diseases in human populations.

Thesaurus Terms:
antiinflammatory agent, chemotherapy, nonhuman therapy evaluation, protease inhibitor, ulcerative colitis chymotrypsin, enzyme activity, inflammation, lipid peroxide laboratory mouse, soybeanNational Institute of General Medical Sciences (NIGMS)

goal of the proposed studies in this proposal is to develop a protease-inhibitor containing product which can be developed commercially as an anti-inflammatory agent for use in IBD. In Phase I of the grant work, it was established that an extract of soybeans containing the protease inhibitor BBIC could be used as an anti-inflammatory agent in an in vivo model of inflammation in which ulcerative colitis (UC) was induced in mice by adding dextran sulfate sodium to the drinking water. In Phase II of the grant work, it will be determined whether BBIC has similar anti-inflammatory effects in an animal model of Crohn's Disease (CD) in which rats are utilized. As part of Phase II of this grant work, a pilot study on the effects of BBIC in UC patients will also be performed. BBIC achieved Investigational New Drug (IND #34671) status from the Food and Drug Administration and human trials to evaluate it as a human cancer chemopreventive agent began in 1992. Proteolytic activity is thought to play a major role in IBD. BBI and BBIC are expected to have major anti-inflammatory effects in patients with UC or CD. It is expected that the results of this human trial will give information about the probability of BBIC having a beneficial effect in the treatment of UC and data to indicate the best biomarkers to utilize in a future Phase II BBIC efficacy trial in patients with IBD.

Thesaurus Terms:
Crohn's disease, antiinflammatory agent, drug design /synthesis /production, gastrointestinal disorder chemotherapy, human therapy evaluation, nonhuman therapy evaluation, protease inhibitor, ulcerative colitis acute phase protein, amyloid protein, biomarker, chymotrypsin, clinical trial, drug screening /evaluation, inflammation, inflammatory bowel disease, proteolysis, remission /regression biopsy, clinical research, human subject, laboratory rat, soybean