Treatment of Sepsis with Talactoferrin

用 Talactoferrin 治疗脓毒症

基本信息

批准号：
7272145
负责人：
ATUL VARADHACHARY
金额：
$ 57.04万
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 2008-09-04
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7272145
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-1 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 TNF gene 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）：严重败血症是全世界发病和死亡的主要原因。它是美国非冠心病重症监护病房 (ICU) 的首要死因，每年发生超过 75 万例病例。这意味着在美国，每天有超过 500 名患者死于严重脓毒症，其中 28% 至 50% 的患者死于疾病过程，每位患者平均损失 22,000 美元。成功开发基于 TLF 的脓毒症疗法将满足重大的未满足的医疗需求。 Agennix 现已建立了医药级 talactoferrin 的生产企业，并在各种适应症的临床研究中证明了其安全性，目前正在与 FDA 合作，以获得启动癌症临床 3 期研究的许可。因此，talactoferrin 的开发正处于这样一个阶段：证明其在脓毒症中的临床功效将使治疗脓毒症的产品的产生走上相对容易和直接的道路。