The Health Benefits of the Bowman-Birk Inhibitor

  • Ann R. Kennedy


There have been numerous reviews on the beneficial effects and health benefits of the soybean protease inhibitor known as the Bowman-Birk Inhibitor (BBI) [1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15]. The early in vitro studies were so promising that in vivo studies were performed at a very early stage of BBI development. The results of animal carcinogenicity studies were sufficiently promising that permission to perform BBI human trials was sought. It was planned that human trials using BBI would be performed with BBI Concentrate (BBIC), a soybean extract enriched in BBI. BBIC achieved Investigational New Drug (IND) Status with the FDA in 1992, and human trials began at that time. There have been six INDs involving BBI human trial work for the following endpoints: cancer prevention (regression of a pre-malignant lesion known as oral leukoplakia), treatment of benign prostatic hyperplasia, prostate cancer detection and treatment (with measurements of prostate specific antigen levels and prostate volume, etc.), treatment of ulcerative colitis, gingivitis, or esophagitis (and/or alleviation of adverse side effects of lung cancer treatment), as described elsewhere [15]. There are numerous publications on the results from these trial areas [16, 17, 18, 19, 20, 21]. In this “expert opinion”, the current status of BBI experimentation and human trials will be discussed.


Multiple Sclerosis Experimental Autoimmune Encephalomyelitis Muscular Dystrophy Human Trial Duchenne Muscular Dystrophy 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. 1.
    Kennedy AR, Szuhaj BF, Newberne PM, Billings PC (1993) Preparation and production of a cancer chemopreventive agent, Bowman-Birk Inhibitor Concentrate. Nutr Cancer 19:281–302PubMedCrossRefGoogle Scholar
  2. 2.
    Kennedy AR (1993) Overview: anticarcinogenic activity of protease inhibitors. In: Troll W, Kennedy AR (eds) Protease Inhibitors as cancer chemopreventive agents. Plenum publishing corporation, New York, pp 9–64 (Chapter)Google Scholar
  3. 3.
    Kennedy AR (1993) In vitro studies of anticarcinogenic protease Inhibitors In: Troll W, Kennedy AR (eds) Protease Inhibitors as cancer chemopreventive agents. Plenum publishing corporation, New York, pp 65–91 (Chapter)Google Scholar
  4. 4.
    Chang JD, Kennedy AR (1993) Suppression of c-myc by anticarcinogenic protease Inhibitors. In: Troll W, Kennedy AR (eds) Protease Inhibitors as cancer chemopreventive agents. Plenum Publishing corporation, New York, pp 265–280 (Chapter)Google Scholar
  5. 5.
    Kennedy AR (1994) Prevention of carcinogenesis by protease Inhibitors. Cancer Res 54:1999s–2005sPubMedGoogle Scholar
  6. 6.
    Kennedy AR (1993) Cancer prevention by protease Inhibitors. Prev Med 22:796–811PubMedCrossRefGoogle Scholar
  7. 7.
    Kennedy AR (1995) The evidence for soybean products as cancer preventive agents. J Nutr 125:733s–743sPubMedGoogle Scholar
  8. 8.
    Kennedy AR (1998) Cancer prevention by Bowman-Birk Inhibitor Concentrate (BBIC). In: Prasad KN, Cole WC (eds) Cancer and Nutrition. IOS Press, Amsterdam, pp 93–98Google Scholar
  9. 9.
    Kennedy AR (1998) The Bowman-Birk Inhibitor from soybeans as an anticarcinogenic agent. Am J Clin Nut 68(suppl):1406S–1412SGoogle Scholar
  10. 10.
    Kennedy AR (1998) Chemopreventive agents: protease Inhibitors. Pharmacol Ther 78:167–209PubMedCrossRefGoogle Scholar
  11. 11.
    Kennedy AR, Wan XS (2002) Biological effects of a soybean-derived protease Inhibitor, the Bowman-Birk Inhibitor. In: Descheemaeker K, Debruyne I (eds) Soy and Health 2002—Clinical evidence, dietetic applications. Garant Publishers, Apeldoorn, p 129–136Google Scholar
  12. 12.
    Kennedy AR (2007) Status of current human trials utilizing Bowman Birk Inhibitor Concentrate. In: Descheemaeker K. Debruyne I (eds) Proceedings of a Symposium, “Soy and Health 2006—Clinical evidence, dietetic applications”, held in Dusseldorf, Germany, October 2006; Garant Publishers, Apeldoorn, pp 73–79Google Scholar
  13. 13.
    Kennedy AR (2009) Protease Inhibitors. In: Knasmüller S, DeMarini DM, Johnson I, Gerhäuser C (eds) Chemoprevention of cancer and DNA damage by dietary factors, Chapter 42, Wiley, GmbH and Co, KGaA, Weinheim, pp 761–767Google Scholar
  14. 14.
    Kennedy AR, Wan XS (2011) Countermeasures for space radiation induced adverse effects. Adv Space Res 48:1460–1479CrossRefGoogle Scholar
  15. 15.
    Kennedy AR (2006) The status of human trials utilizing Bowman-Birk Inhibitor Concentrate from soybeans. In: Sugano M (ed) Soy in health and disease prevention. CRC Press, Taylor and Francis Group LLC, Chapter 12, Boca Raton, Florida, USA, pp 207–223 (Chapter)Google Scholar
  16. 16.
    Armstrong WB, Kennedy AR, Wan XS, Atiba J, McLaren CE, Meyskens FL Jr (2000) Single dose administration of Bowman-Birk Inhibitor Concentrate (BBIC) in patients with oral leukoplakia. Cancer Epidemiol Biomark Prev 9:43–47Google Scholar
  17. 17.
    Armstrong WB, Kennedy AR, Wan XS, Taylor TH, Nguyen QA, Jensen J, Thompson W, Lagerberg W, Meyskens FL Jr (2000) Clinical modulation of oral leukoplakia and protease activity by Bowman-Birk Inhibitor Concentrate in a phase IIa chemoprevention trial. Clin Cancer Res 6:4684–4691PubMedGoogle Scholar
  18. 18.
    Malkowicz SB, McKenna WG, Vaughn DJ, Wan XS, Propert KJ, Rockwell K, Marks SHF, Wein AJ, Kennedy AR (2001) Effects of Bowman-Birk Inhibitor Concentrate in patients with benign prostatic hyperplasia. Prostate 48:16–28PubMedCrossRefGoogle Scholar
  19. 19.
    Armstrong WB, Wan XS, Kennedy AR, Taylor TH, Meyskens FL (2003) Development of the Bowman-Birk Inhibitor for oral cancer chemoprevention and analysis of neu immunohistochemical staining intensity with Bowman-Birk Inhibitor Concentrate treatment. Laryngoscope 113(10):1687–1702PubMedCrossRefGoogle Scholar
  20. 20.
    Lichtenstein GR, Deren JJ, Katz S, Lewis JD, Kennedy AR, Ware JH (2008) Bowman-Birk Inhibitor Concentrate (BBIC): a novel therapeutic agent for patients with active ulcerative colitis. Dig Dis Sci 53(1):175–180Google Scholar
  21. 21.
    Lin L, Mick M, Ware J, Metz J, Lustig R, Vapiwala N, Rengan R, Kennedy AR (2009) Phase I randomized double-blind placebo controlled single dose safety studies of Bowman Birk Inhibitor Concentrate. (submitted)Google Scholar
  22. 22.
    Bowman DE (1046) Differentiation of soybean antitryptic factors. Proc Soc Exp Biol Med 63:547–550Google Scholar
  23. 23.
    Birk Y (1961) Purification and some properties of a highly active Inhibitor of trypsin and α-chymotryotrypsin from soybeans. Biochim Biophys Acta 54:378–381PubMedCrossRefGoogle Scholar
  24. 24.
    Morris CA, Morris LD, Kennedy AR, Sweeney HL (2005) Attenuation of skeletal muscle atrophy via protease inhibition. J Appl Physiol 99(5):1719–1727PubMedCrossRefGoogle Scholar
  25. 25.
    Arbogast S, Smith J, Matuszczak Y, Hardin B, Moylan J, Smith JD, Ware J, Kennedy AR, Reid MB (2007) Bowman-Birk Inhibitor Concentrate prevents atrophy, weakness and oxidative stress in soleus muscle of lindlimb-unloaded mice. J Appl Physiol 102(3):956–964PubMedCrossRefGoogle Scholar
  26. 26.
    Morris CA, Selsby JT, Morris LD, Pendrak K, Sweeney HL (2010) Bowman-Birk Inhibitor attenuates dystrophic pathology in mdx mice. J Appl Physiol 109(5):1492–1499PubMedCrossRefGoogle Scholar
  27. 27.
    Gran B, Tabibzadeh N, Martin A, Ventura ES, Ware JH, Zhang G-X, Parr JL, Kennedy, AR, Rostami A (2006) The protease Inhibitor, Bowman-Birk Inhibitor, suppresses experimental autoimmune encephalomyelitis: a potential oral therapy for multiple sclerosis. Multiple Scler 12(6):688–697Google Scholar
  28. 28.
    Touil T, Ciric B, Ventura E, Shindler KS, Gran B, Rostami A (2008) Bowman-Birk Inhibitor suppresses autoimmune inflammation and neuronal loss in a mouse model of multiple sclerosis. J Neurol Sci 27(1–2):191–202CrossRefGoogle Scholar
  29. 29.
    Dai H, Ciric B, Zhang GX, Rostami A (2011) Bowman-Birk Inhibitor attenuates experimental autoimmune encephalomyelitis by delaying infiltration of inflammatory cells into the CNS. Immunol Res 51(2–3):145–152PubMedCrossRefGoogle Scholar
  30. 30.
    Dai H, Ciric B, Zhang GX, Rostami A (2012) Interleukin-10 plays a crucial role in suppression of experimental autoimmune encephalomyelitis by Bowman-Birk Inhibitor. J Neuroimmunol 245(1–2):1–7PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  1. 1.Department of Radiation Oncology, Perelman School of MedicineUniversity of PennsylvaniaPhiladelphiaUSA

Personalised recommendations