Monoclonal Antibody for Treatment of Inhalation Anthrax

描述（由申请人提供）：Elusys Therapeutics正在积极开发一种新型，超高亲和单克隆抗体（Mab），以中和炭疽毒素的致命作用。Elusys的单抗eti204是针对炭疽杆菌的保护性抗原（PA），正在开发用于预防和治疗由生物恐怖袭击引起的炭疽感染。炭疽目前被联邦政府认为是头号生物战威胁。在小鼠和兔子的研究中，eiti -204保护了100%的治疗动物，使其免于因接触炭疽毒素或吸入孢子而死亡。由于这些令人信服的数据，该公司正在根据反恐办公室（OCTAP）和FDA会议的意见，迅速寻求一个明确的临床开发计划。这项申请是为了资助完成最终的动物功效测试，人体安全性测试和药物制造，这些都是申请FDA批准etii -204治疗炭疽感染在暴露前后的情况下所必需的。

DESCRIPTION (provided by applicant): Elusys Therapeutics is actively developing a novel, ultra high-affinity monoclonal antibody (Mab) to neutralize the lethal effects of anthrax toxin. Elusys's Mab, ETI-204, is directed against Protective Antigen (PA) of B. anthracis and is being developed for both prophylactic and therapeutic treatment of anthrax infections resulting from a bioterrorist attack. Anthrax is currently considered by the federal government to be the number one biowarfare threat. In both mouse and rabbit studies, ETI-204 has protected 100% of treated animals from death following exposure to anthrax toxin or inhaled spores. As a result of this compelling data, the Company is rapidly pursuing a well defined clinical development program with input from meetings with both the Office of Counterterrorism (OCTAP) and the FDA. This application is for funding to complete the final animal efficacy testing, human safety testing and pharmaceutical manufacturing necessary to apply for FDA approval of ETI-204 for treatment of anthrax infection in both pre- and post exposure situations. The specific aims of this application are: (1) to develop a scaleable ETI-204 manufacturing process; (2) to complete definitive efficacy testing in a primate spore challenge model: (3) to produce clinical-grade ETI- 204; and (4) to complete human safety trials. Due to the urgent national need for an effective anthrax therapeutic, Elusys, with funding from DoD, has already initiated and will have completed several additional animal efficacy and PK studies to further ensure the success of ETI-204's continued development as outlined in this application. Funding provided under this application would greatly facilitate and expedite the final development work necessary to validate the safety and efficacy of a much needed anthrax antidote to protect both military and civilian personnel.