Phase I Study of Oral Bowman-Birk Inhibitor Concentrate [Bbic], a Soy Protein, on Patients With Lower Urinary Tract Symptoms

Broderick, Gregory A.; Zoltick, Barbara H.; Marks, Sheldon H. F.; Treat, Joseph; Tomaszewski, John E.; Propert, Kathleen J.; Wein, Alan J.; Kennedy, Ann R.

doi:10.1097/00005392-199904010-00914

Cited by 6 publications

(6 citation statements)

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“…[145][146][147][148][149][150][151][152][153][154] Soy may also have other anticancer effects not related to phytoestrogens. 156 There is conflicting scientific information regarding the actual health benefit of soy at this time. Although the antiestrogenic effects of soy may mimic the beneficial effects of pharmacological antiestrogens such as tamoxifen, soy can also be proestrogenic, demonstrating adverse effects on markers of cancer risk in breast tissues.…”

Section: Soymentioning

confidence: 99%

“…Soy, soy‐containing foods, and soy components such as isoflavones, exert both estrogenic and antiestrogenic effects 145 – 154 . Soy may also have other anticancer effects not related to phytoestrogens 156 . There is conflicting scientific information regarding the actual health benefit of soy at this time.…”

Section: Nutritional Issues For Common Cancer Sitesmentioning

confidence: 99%

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Nutrition During and After Cancer Treatment: A Guide for Informed Choices by Cancer Survivors

Brown

Byers

Thompson³

et al. 2001

CA: A Cancer Journal for Clinicians

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Many studies have been conducted about dietary interventions aimed at preventing cancer. The American Cancer Society has published guidelines on diet, nutrition and cancer prevention, which are updated periodically as new evidence emerges, and other groups, too, have issued statements or guidelines about nutritional strategies to prevent cancer. Much less is known, however, about optimal nutrition for cancer survivors.This report looks at the different phases of cancer survivorship, from active treatment to advanced disease, and presents existing evidence from which informed decisions can be made regarding dietary choices. Popular complementary and alternative methods related to dietary intervention are reviewed. Nutrition information is also provided according to common cancer sites.As this is an area that requires survivors and health care providers to communicate effectively, a special section on "frequently asked questions" is provided for use as a patient education

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Section: Soymentioning

confidence: 99%

Section: Nutritional Issues For Common Cancer Sitesmentioning

confidence: 99%

Nutrition During and After Cancer Treatment: A Guide for Informed Choices by Cancer Survivors

Brown

Byers

Thompson³

et al. 2001

CA: A Cancer Journal for Clinicians

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“…Four human trials utilizing BBIC have been completed previously ( 13 – 15 , 22 – 24 ). Phase I and phase IIa studies of BBIC in patients with oral leukoplakia were also performed ( 13 , 15 , 22 , 23 ).…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2014

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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.

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“…Human serum samples used in the present study were obtained from 19 male patients enrolled in a 6-mo Phase I BBIC clinical trial, which has been described in detail elsewhere (9,12). In that trial, placebo or BBIC tablets were administered orally at 100, 200, 400, or 800 CI units/day for 6 mo.…”

Section: Serum Samples From Patients Treated With Bbicmentioning

confidence: 99%

“…Studies in animals have demonstrated that BBIC is well tolerated by dogs (5), rats (6), and mice (7) at up to 1,000 mg/kg/day without significant drug-induced toxicity (5)(6)(7)(8). Human studies have also shown that BBIC is not toxic at ≤800 or 1,066 chymotrypsininhibition (CI) units/day (9)(10)(11)(12); 1 CI unit is defined as the amount of protease inhibitor needed to inhibit 1 mg of bovine pancreatic α-chymotrypsin (13). In a Phase IIa oral cancer prevention trial in patients with oral leukoplakia, treatment with BBIC at 200-1,066 CI units/day for 1 mo resulted in a dose-dependent decrease in oral lesion size (11).…”

Section: Introductionmentioning

confidence: 99%

Detection of Bowman-Birk Inhibitor and Anti-Bowman-Birk Inhibitor Antibodies in Sera of Humans and Animals Treated With Bowman-Birk Inhibitor Concentrate

Wan

Serota²,

Ware³

et al. 2002

Nutrition and Cancer

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The Bowman-Birk inhibitor (BBI) is a soybean-derived serine protease inhibitor with anticarcinogenic activities. BBI, in the form of BBI concentrate (BBIC), is currently being evaluated in clinical trials as a human cancer-preventive agent. In the present study, an enzyme-linked immunosorbent assay was used to measure BBI concentrations in serum samples collected from human subjects and animals treated with BBIC. The results demonstrate that the serum BBI concentration was higher than the baseline level for the patients after treatment with BBIC at 100-800 chymotrypsin-inhibitor units/day for 0.5, 1, 2, 4, and 6 mo. The increase in serum BBI concentration was also observed in dogs treated with BBIC at 100-1,000 mg/kg/day for 52 wk, and the increase was dose dependent. The results also indicate that anti-BBI antibodies were present in animals and the serum levels of anti-BBI antibodies increased significantly in mice treated with BBIC at 100-1,000 mg/kg/day for 15 and 26 wk. The increase in the serum level of anti-BBI antibodies in dogs treated with BBIC was not statistically significant, and no increase in the serum level of anti-BBI antibodies was observed in human subjects after BBIC treatment. These results suggest that orally ingested BBI is absorbed by human subjects and animals and that some animals develop antibodies to BBI in response to treatment with BBIC.

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Phase I Study of Oral Bowman-Birk Inhibitor Concentrate [Bbic], a Soy Protein, on Patients With Lower Urinary Tract Symptoms

Cited by 6 publications

References 0 publications

Nutrition During and After Cancer Treatment: A Guide for Informed Choices by Cancer Survivors

Nutrition During and After Cancer Treatment: A Guide for Informed Choices by Cancer Survivors

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

Detection of Bowman-Birk Inhibitor and Anti-Bowman-Birk Inhibitor Antibodies in Sera of Humans and Animals Treated With Bowman-Birk Inhibitor Concentrate

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