Overall Adverse Event Rates Dose Group Any Adverse Event (%) GI Adverse Events (%) Discontinuation Due to AE (%) Placebo 72.1% 32.6% 0% 1 mg 88.6% 48.6% 2.9% 4 mg (escalated) 88.6% 60.0% 5.7% 4 mg (single dose) 90.9% 63.6% 6.1% 8 mg (escalated) 87.5% 57.5% 5.0% 8 mg (single dose) 88.6% 62.9% 5.7% 12 mg (escalated) 97.2% 66.7% 8.3% Source: Jastreboff AM, Kaplan LM, Fras JP, et al
Peptide Vials (TB500, 5 mg each): 8 weeks 8 vials 12 weeks 12 vials 16 weeks 16 vials Insulin Syringes (U100): Per week: 7 syringes (1/day) 8 weeks: 56 syringes 12 weeks: 84 syringes 16 weeks: 112 syringes Bacteriostatic Water (10 mL bottles): Use ~3.0 mL per vial for reconstitution
Int J Antimicrob Agents 32(3):262266 Suzuki H, Kato K, Kumagai H (2004) Development of an efficient enzymatic production of gamma-d-glutamyl-l-tryptophan (SCV-07), a prospective medicine for tuberculosis, with bacterial gamma-glutamyltranspeptidase
Acta 1091, 145150
Nevertheless, the exact mechanism(s) by which endotoxins (LPS) cross the intestinal barrier remain to be elucidated