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Biologic Treatment for Sepsis

Summary

Sepsis (blood poisoning) is a life-threatening and complex clinical syndrome resulting from the body’s inflammatory reaction to infection. Cardiovascular dysfunction is a common feature and contributes to the development of multiple organ failure associated with an extremely high mortality rate (~50%). Tumor necrosis factor (TNF-α), a pro-inflammatory cytokine, is produced and is one of the main mediators of cardiovascular dysfunction. Sepsis is a leading cause of death globally, and a major contributor to morbidity, mortality and costs in intensive care. Yet there is currently only one approved therapeutic product on the market. This has demonstrated a minor improvement in the absolute reduction of mortality in severe sepsis, but is contraindicated in many patients due to potentially serious side-effects, such as severe bleeding (Bernard et. al. 2001. NEJM. 344: 699-709; Abraham et. al. 2005. NEJM. 353: 1332-1341). To date none of the alternatives have demonstrated substantial promise in advanced trials. The failure of many drugs may be due to their single mode of action in treating a complex syndrome. New drugs, with minimal side-effects, capable of intervening at multiple points in the sepsis cascade are desperately needed. The global market for an effective and safe sepsis treatment is estimated to be over $8 billion annually.
Description of the Invention This biologic is a protein with potent anti-inflammatory, anti-apoptotic and anti-coagulant effects. Our scientists have discovered that it significantly reduces myocardial TNF-α and interleukin (IL-β) production during sepsis, resulting in significant improvement in cardiac function and survival in clinically relevant animal models. They have also discovered a novel interaction with toll-like receptor 4 (TLR4) which means the biologic may compete with bacterial endotoxin binding to combat the onset of sepsis.
败血症是一个因感染而产生有害宿主反应所造成的复杂临床综合症。其特征为肿瘤坏死因子–阿尔法的产生。此促炎性细胞因子已被证明是心血管机能障碍主要的原因之一。心血管机能障碍是败血症患者普遍患有的疾病，其促进多器官功能衰竭扩展的作用所导致的相关死亡率高达约50%。败血症是全球主要的死亡原因之一，然而目前市场上却只有一项被批准的治疗药物经确认可以轻微减少败血症重症患者的死亡率，而非重症患者却不在其目标患者群体内。许多患者也因包括严重出血等潜在的严重副作用被禁止使用此产品（Bernard et. al. 2001. NEJM. 344: 699-709; Abraham et. al. 2005. NEJM. 353: 1332-1341）。除此之外，迄今为止所临床发展出的极少的可选替代品并没有在试验中展现出实质性的承诺。针对一个复杂的综合征却以一个单一的模式采取行动可能是许多败血症治疗药物失败的原因。目前迫切需要的是一种含有最小副作用并可以在多点介入败血症的病程发展以降低死亡率的药物。有效、安全的败血症疗法据估计约有每年$80亿的全球市场。
发明介绍 此生物医药产品是一种具备有效消炎、抗细胞凋亡以及抗凝血作用的多功能蛋白。我们的研究人员已发现，此药物明显地减少了由败血症而产生的心肌肿瘤坏死因子-α与白细胞介素-β数量，在败血症临床相关动物模型中有效地改善了心脏的功能与存活能力。我们同时发现了此生物医药产品与Toll样受体4（TLR4）的相互作用，可先一步与TLR4结合，从而防止细菌内毒素与TLR4结合并引发败血症。
A novel prophylactic and therapeutic treatment for sepsis that improves cardiac function and reduces mortality
It significantly reduces myocardial TNF-α and IL-β production during sepsis
It interacts directly with TLR4 receptors and may inhibit TLR4-mediated sepsis initiation/escalation by bacterial endotoxin
A multi-faceted therapeutic protein with potent anti-inflammatory, anti-apoptotic, and anti-coagulant effects
Its anti-coagulant activity is mild and not expected to generate bleeding related side-effects
It may improve the function of multiple organs in sepsis and has therapeutic potential for other inflammatory conditions
一项可以改善心脏功能并降低死亡率的创新败血症预防性疗法
显著地减少败血症中心肌肿瘤坏死因子-阿尔法与白细胞介素-贝塔的产生
与TLR4受体的相互直接影响可抑制由细菌内毒素引发或升级的TLR4介导败血症
一种具备有效消炎、抗细胞凋亡以及抗凝血作用的多方位蛋白
此产品抗凝血性能温和，预计将不会产生与出血相关的副作用
可改善败血症中其他身体器官的机能，并有潜力对其他炎症性疾病的治疗做出贡献

Type of Cooperation

技术售让

Coverage Areas

生物技术/制药/医疗

Goods and Services

医疗器械/医疗设备