[Anti Shiga-like toxin II(SLT-II) humanized monoclonal antibody].
Anti-Shiga-Like Toxin II(SLT-II) Humanized Monoclonal Antibody(TMA-15) was constructed from Mouse Monoclonal Antibody(MuVTm1.1) recognizing the same antigen using recombinant and CDR grafting technology. TMA-15 had almost the same affinity to SLT-II as MuVTm1.1 and showed the good protective activity of mice challenged either with SLT-II or with SLT-II secreting Shiga-like Toxin producing E. coli(STEC). TMA-15 showed no acute toxicity to monkeys and no cross-reactivity to human tissues in pre-clinical safety studies. From the preliminary results of Phase 1 clinical trial using healthy adult volunteers, doses up to planned maximum dose were well tolerated and TMA-15 showed long half life in blood almost comparable to gamma globulin preparations. Therefore, TMA-15 is expected to show clinical efficacy in coming clinical trial using pediatric STEC patients.
Matsumoto
Yoh-ichi
Y
Pharmaceutical Development Department 1, Teijin Ltd.
D000818:Animals; D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic; D004195:Disease Models, Animal; D004926:Escherichia coli / Q000378:metabolism; D004927:Escherichia coli Infections / Q000188:drug therapy; D006463:Hemolytic-Uremic Syndrome / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D051379:Mice; D022641:Shiga Toxin 2 / Q000096:biosynthesis / Q000276:immunology*
D000911:Antibodies, Monoclonal; D022641:Shiga Toxin 2