Treatment of Sepsis with Talactoferrin

用 Talactoferrin 治疗脓毒症

基本信息

批准号：
7673166
负责人：
ATUL VARADHACHARY
金额：
$ 164.14万
依托单位：
AGENNIX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-10 至 2010-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7673166
关键词：
Adverse event Animal Model Anti-Inflammatory Agents Attenuated Biological Markers C-reactive protein Caring Cause of Death Clinical Clinical Research Clinical Trials Coronary Care Units Data Development Disease Double-Blind Method Drug usage End Point Enrollment Evaluation Feces Financial Support Functional disorder Generations Human Incidence Intensive Care Units Interleukin-10 Interleukin-6 Iron Laboratories Lactoferrin Literature Malignant Neoplasms Medical Monitor Morbidity - disease rate Numbers Oral Organ failure Patients Performance Pharmaceutical Preparations Pharmacodynamics Pharmacologic Substance Phase Phase III Clinical Trials Placebos Population Process Publishing Randomized Recombinants Route Safety Score Sepsis Series Serious Adverse Event Serum Severities Shock Staging Standards of Weights and Measures United States United States Food and Drug Administration Ventilator base clinical efficacy cost cytokine day efficacy trial experience mortality pre-clinical procalcitonin protective effect research study

项目摘要

DESCRIPTION (provided by applicant): Severe sepsis is a major cause of morbidity and mortality throughout the world. It is the leading cause of death in non-coronary intensive care units (ICUs) in the United States, with more than 750,000 cases occurring every year. This means that in the United States, more than 500 patients die from severe sepsis every day, with 28% to 50% of the patients succumbing to the disease process at an average cost of $22,000 per patient. Successful development of TLF-based therapy for sepsis would satisfy a significant unmet medical need. Agennix has now established a manufacture of a pharmaceutical-grade talactoferrin, it has demonstrated its safety in clinical studies for various indications, and is now interacting with the FDA to obtain a go-ahead to initiate clinical Phase 3 studies in cancer. The development of talactoferrin is therefore at a stage that a demonstration of its clinical efficacy in sepsis would put the generation of a product to treat sepsis on a relatively easy and straightforward path.

描述（由申请人提供）：严重的败血症是全世界发病率和死亡率的主要原因。这是美国非冠军重症监护病房（ICU）的主要死亡原因，每年发生75万多个案件。这意味着，在美国，每天有500多名患者死于严重的败血症，其中28％至50％的患者屈服于疾病过程，平均每名患者$ 22,000。成功开发基于TLF的败血症疗法将满足大量未满足的医疗需求。 Agennix现在已经建立了药物级塔拉乳铁蛋白的制造，它在各种适应症的临床研究中证明了其安全性，现在正在与FDA相互作用，以获得启动癌症临床3阶段研究的GO-AED。因此，塔拉托菲蛋白的发育正处于败血症中其临床疗效的阶段，将产生产物以相对简单明了的路径来处理败血症。