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Lin LL, Mick R, Ware J, et al. Phase I randomized double-blind placebo-controlled single-dose safety studies of Bowman-Birk inhibitor concentrate. Oncol Lett. 2014;7(4):1151-1158doi: 10.3892/ol.2014.1855.
Lin, L. L., Mick, R., Ware, J., Metz, J., Lustig, R., Vapiwala, N., Rengan, R., & Kennedy, A. R. (2014). Phase I randomized double-blind placebo-controlled single-dose safety studies of Bowman-Birk inhibitor concentrate. Oncology letters, 7(4), 1151-1158. https://doi.org/10.3892/ol.2014.1855
Lin, Lilie L, et al. "Phase I randomized double-blind placebo-controlled single-dose safety studies of Bowman-Birk inhibitor concentrate." Oncology letters vol. 7,4 (2014): 1151-1158. doi: https://doi.org/10.3892/ol.2014.1855
Lin LL, Mick R, Ware J, Metz J, Lustig R, Vapiwala N, Rengan R, Kennedy AR. Phase I randomized double-blind placebo-controlled single-dose safety studies of Bowman-Birk inhibitor concentrate. Oncol Lett. 2014 Apr;7(4):1151-1158. doi: 10.3892/ol.2014.1855. Epub 2014 Feb 05. PMID: 24944684; PMCID: PMC3961219.
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Oncol Lett. 2014 Apr;7(4):1151-1158. doi: 10.3892/ol.2014.1855. Epub 2014 Feb 05.

Phase I randomized double-blind placebo-controlled single-dose safety studies of Bowman-Birk inhibitor concentrate.

Oncology letters

Lilie L Lin, Rosemarie Mick, Jeffrey Ware, James Metz, Robert Lustig, Neha Vapiwala, Ramesh Rengan, Ann R Kennedy

Affiliations

  1. Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.
  2. Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.

PMID: 24944684 PMCID: PMC3961219 DOI: 10.3892/ol.2014.1855

Abstract

In previously performed animal studies and Phase I-II human trials, Bowman-Birk inhibitor concentrate (BBIC) appeared to be a promising cancer chemopreventive agent. The present study describes the results of two phase I randomized double-blind placebo-controlled trials performed in male subjects to assess the safety and toxicity of the original and new formulations of BBIC administered in a single dose as a suspension in orange juice. The dose of BBIC varied from 800-2,000 chymotrypsin inhibitor (CI) units. The BBI concentration in the serum samples collected from the subjects was analyzed by a dot-blot analysis procedure using the 5G2 monoclonal antibody, which is specific for reduced BBI. A total of 41 subjects were enrolled, 20 in the initial BBIC study and 21 in the second BBIC study. In these human trials, no clinically relevant changes in hematological or biochemical parameters were observed. Overall, BBIC was found to be well-tolerated. For these BBIC single-dose phase I trials, there was no dose-limiting toxicity for BBIC, even at the highest dose evaluated, and there were no apparent differences between the clinical trial results for the two formulations of BBIC. The bioavailability of BBI in the second clinical trial, which used the new BBIC formulation, was approximately 40 to 43% of the BBI bioavailability reached in the first clinical trial, which used the original BBIC formulation. The observed bioavailability difference was attributed to the different BBIC formulations used in these two clinical trials. These trials demonstrated that BBIC is safe when administered in a single dose of up to 2,000 CI units. Therefore, the results from the two trials indicate that a multi-dose trial of BBIC may be safely performed with doses of up to 2,000 CI units per day.

Keywords: Bowman-Birk inhibitor; Bowman-Birk inhibitor concentrate; cancer prevention; soybean

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