Anthrax Immune Globulin to Prevent & Treat Anthrax: Clinical Development

描述（由申请人提供）：已获得许可的炭疽疫苗BioThrax（r）可增强保护性免疫力，由多种抗体组成，可预防炭疽。这些纯化形式的炭疽免疫球蛋白可给予吸入性炭疽的受害者，以提供针对药物敏感的、重要的是针对B的耐药菌株的立即保护性免疫。炭疽病本文提出的是静脉给药炭疽免疫球蛋白（AIGIV）的临床开发，用于预期适应症“治疗由过敏性和耐药性B引起的吸入性炭疽”。炭疽病在18-65岁的人。“我们会为有接触或曾经接触过抗药性及╱或敏感性B的人士寻求额外的指标，以预防吸入性炭疽病。”炭疽病（接触前和接触后预防）。本文提出了一种单一的、剂量范围的、安慰剂对照的临床试验，以测试AIGIV（抗PA IgG和毒素中和活性，TNA）的耐受性和药代动力学。在本申请范围之外，Emergent ImmunoSolutions将生产并放行一个cGMP批次的AIGIV，并在家兔和NHP模型中进行“动物规则”有效性研究。Emergent ImmunoSolutions已经从BioThrax（r）免疫的个体中收集了血浆，用于使用FDA批准的免疫球蛋白纯化工艺生产AIGIV。AIGIV的第一个临床批次将用于“动物规则”研究，以确定提供针对雾化B的预防和治疗保护的剂量。炭疽孢子攻击。该信息连同来自AIGIV的拟定剂量范围、安全性和药代动力学试验的数据将用于推导AIGIV的人剂量。FDA批准的炭疽疫苗产生源血浆和FDA批准的AIGIV生产工艺的结合提供了一种低风险途径，可以及时提供有效的、可获得许可的炭疽治疗剂，以满足供应国家战略储备的重要需求。通过多克隆抗体靶向多个表位，在治疗和预防吸入性炭疽中具有比单一单克隆抗体潜在的优势。 Emergent BioSolutions是一家生物制品公司，专注于研究、开发和制造新型疫苗及相关产品，用于预防和治疗常见疾病和大规模杀伤性生物武器。其子公司为BioPort Corporation（主要生产运营），总部位于密歇根州兰辛;以研究为重点的Emergent ImmunoSolutions（位于马里兰州盖瑟斯堡）;以及以研究为重点的Emergent Europe Limited（位于英格兰阅读）。有关Emergent BioSolutions及其子公司的更多信息，请访问www.ebsi.com。

DESCRIPTION (provided by applicant): The licensed anthrax vaccine, BioThrax(r), elicits protective immunity consisting of multiple antibodies that protect against anthrax. In purified form, these anthrax immune globulins can be administered to victims of inhalational anthrax to provide immediate protective immunity against drug-sensitive, and importantly, drug- resistant strains of B. anthracis. Proposed herein is the clinical development of Anthrax Immune Globulin for intravenous administration (AIGIV) for the intended indication of the "Treatment of inhalational anthrax due to antibiotic-susceptible and antibiotic-resistant B. anthracis in persons 18-65 years of age." An additional indication will be sought for the prophylaxis of inhalational anthrax for individuals at risk for having contact with, or who have contacted, either antibiotic-resistant and/or antibiotic-susceptible B. anthracis (pre- exposure and post-exposure prophylaxis). Proposed herein is a single, dose-ranging, placebo-controlled clinical trial to test the tolerability and pharmacokinetics of AIGIV (anti-PA IgG and Toxin Neutralizing Activity, TNA). Outside the scope of this application Emergent ImmunoSolutions will manufacture and release one cGMP lot of AIGIV and conduct "Animal Rule" efficacy studies in rabbit and NHP models. Emergent ImmunoSolutions has collected plasma from BioThrax(r)-immunized individuals for the manufacture of AIGIV using an FDA-approved process for immune globulin purification. The first clinical lot of AIGIV will be used for "Animal Rule" studies to determine the doses providing preventative and therapeutic protection against aerosolized B. anthracis spore challenge. This information together with data from the proposed dose- ranging, safety and pharmacokinetic trial of AIGIV will be used to derive the human dose of AIGIV. The coupling of an FDA-approved anthrax vaccine to generate Source Plasma and an FDA-approved process for the production of AIGIV provides a low-risk path to the timely delivery of an efficacious, licensable anthrax therapeutic to fulfill the vital need to supply the Strategic National Stockpile. The targeting of multiple epitopes by polyclonal antibodies has potential advantages over a single monoclonal antibody for the treatment and prevention of inhalational anthrax. Emergent BioSolutions is a biologics company focused on the research, development and manufacture of novel vaccines and related products for prophylactic and therapeutic use against common diseases and biological weapons of mass destruction. Its subsidiaries are BioPort Corporation, the primary manufacturing operation, headquartered in Lansing, Michigan; research-focused Emergent ImmunoSolutions, located in Gaithersburg, Maryland; and research- focused Emergent Europe Limited, located in Reading, England. More information about Emergent BioSolutions and its subsidiaries can be found at www.ebsi.com.