ABSTRACT
The soybean-derived protease inhibitor known as the Bowman–Birk inhibitor (BBI) has many preventive and therapeutic effects for various diseases and adverse conditions that have led to its use in several human trials. This chapter reviews the status of BBI use in human trials. BBI, in the form of a soybean extract enriched in BBI and known as BBI concentrate (BBIC), achieved investigational new drug (IND) status with the Food and Drug Administration (FDA) in 1992, and human trials began at that time. There are currently six INDs involving BBIC trials in patients with oral leukoplakia, benign prostatic hyperplasia, prostate cancer, esophagitis/lung cancer, ulcerative colitis (UC), and gingivitis. A new prostate cancer prevention program utilizing BBIC has recently begun, and new trial areas utilizing BBIC in patients with multiple sclerosis, muscular dystrophy, and muscle atrophy from bed rest resulting from spinal cord injuries are expected to begin in the near future.
