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Single-Dose Administration of Bowman-Birk Inhibitor Concentrate in Patients with Oral Leukoplakia

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TLDR
Single-dose BBI concentrate administered as a single oral dose to 24 subjects with oral leukoplakia was well tolerated and appeared to be nontoxic, and further investigation in Phase II clinical trials is being done.
Abstract
The Bowman-Birk inhibitor (BBI) is a soybean-derived serine protease inhibitor and a potential cancer chemopreventive agent for humans. In this Phase I clinical trial, BBI concentrate was administered as a single oral dose to 24 subjects with oral leukoplakia. Pharmacokinetics of BBI was analyzed, and subjects were monitored clinically for toxic effects. Subjects received between 25 and 800 chymotrypsin inhibitor units (CIU) of the compound in a dose escalation trial. BBI was taken up rapidly, and a metabolic product of BBI was excreted in the urine within 24-48 h. No clinical or laboratory evidence of toxicity was observed in the study. Protease activity was also measured in buccal cells to evaluate usefulness as a biomarker. Single-dose BBI concentrate administered up to 800 CIU was well tolerated and appeared to be nontoxic. Further investigation in Phase II clinical trials is being done.

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References
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A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding

TL;DR: This assay is very reproducible and rapid with the dye binding process virtually complete in approximately 2 min with good color stability for 1 hr with little or no interference from cations such as sodium or potassium nor from carbohydrates such as sucrose.
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Nonparametric statistics for the behavioral sciences

Sidney Siegel
TL;DR: This is the revision of the classic text in the field, adding two new chapters and thoroughly updating all others as discussed by the authors, and the original structure is retained, and the book continues to serve as a combined text/reference.
Journal ArticleDOI

Soy intake and cancer risk: A review of the in vitro and in vivo data

TL;DR: There is sufficient evidence of a protective effect to warrant continued investigation of the role of soyfoods in cancer prevention, and in vitro, animal, and epidemiological data are examined.
Journal ArticleDOI

The Role of Soy Products in Reducing Risk of Cancer

TL;DR: The recent workshop on The Role of Soy Products in Cancer Prevention, sponsored by the National Cancer Institute, had two objectives: to evaluate the role of soybean, food products derived from soybeans, and specific components of soybeans in the dietary prevention of cancer and to recommend research initiatives and approaches for further studies of the effect of soy intake on human cancer risk.
Journal ArticleDOI

Chemopreventive agents: protease inhibitors

TL;DR: The soybean-derived protease inhibitor, Bowman-Birk inhibitor, is a potent chymotrypsin inhibitor that has been extensively studied for its ability to prevent carcinogenesis in many different model systems and is believed to play a major role in the prevention and/or treatment of several different diseases, in addition to cancer.
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