Treatment of Sepsis with Talactoferrin

描述(由申请人提供)：严重的脓毒症是全世界发病率和死亡率的主要原因。它是美国非冠状动脉重症监护病房(ICU)的主要死亡原因，每年发生超过75万例。这意味着在美国，每天有500多名患者死于严重的脓毒症，其中28%到50%的患者死于这种疾病过程，每个患者的平均成本为22,000美元。基于TLF的脓毒症治疗方法的成功开发将满足一个重大的未得到满足的医疗需求。Agennix现在已经建立了一种药用级别的talactoferrin的生产，它已经在各种适应症的临床研究中证明了它的安全性，现在正在与FDA互动，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，即证明其在脓毒症中的临床疗效将使产生一种治疗脓毒症的产品走上相对容易和直接的道路。

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.