Development of Fludase for Prevention of Influenza

预防流感的 Fludase 的开发

• 批准号: 7105473
• 负责人: MANG YU
• 金额: $ 200万
• 依托单位: NEXBIO, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-15 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7105473
• 关键词: antiviral agents; chemoprevention; clinical research; clinical trial phase I; dogs; drug design /synthesis /production; drug screening /evaluation; human subject; human therapy evaluation; influenza; inhalation drug administration; laboratory rabbit; laboratory rat; microorganism mass culture; patient oriented research; recombinant proteins; respiratory disorder chemotherapy; respiratory epithelium; virus receptors

DESCRIPTION (provided by applicant): Influenza is characterized by recurrent annual epidemics and periodic major worldwide pandemics. Because of the high disease-related morbidity and mortality, direct and indirect socio-economic impacts of influenza are enormous. In the last 100 years, there have been 3 major influenza pandemics. It has been about thirty years since the last pandemic. A new pandemic is considered imminent and one of the biggest challenges facing public health systems today. With recent technical progress, it has also become possible for bio-terrorists to create potential pandemic viral strains faster than natural evolution of the viruses. Therefore, a broad-spectrum therapeutic/prophylactic product for influenza is critically needed. We have identified a drug lead, Fludase(tm), which targets on all strains and subtypes of influenza including the potential pandemic strains. With the funding from a Phase I Biodefense SBIR application, we have demonstrated its efficacy against a variety of influenza viruses. Unlike the currently available Flu vaccines, Fludase(tm) does not need to be updated yearly. Fludase(tm) can be produced cost effectively and can be readily available at the onset of a natural pandemic or bio-warfare, and for annual epidemics. As a protein-based therapeutic agent administered topically and locally, Fludase(tm) can also potentially avoid the side effects and the risk of generating drug resistant viruses associated with the currently available expensive antiviral compounds. The objective of this grant application is to complete all necessary pre-clinical development and to initiate early stage clinical development of Fludase(tm).

描述（由申请人提供）：流感的特征是每年反复流行和周期性的全球大流行。由于与疾病相关的发病率和死亡率很高，流感的直接和间接社会经济影响是巨大的。在过去的100年里，有三次大规模的流感大流行。自上次大流行以来，已经过去了大约30年。一场新的大流行病被认为迫在眉睫，也是当今公共卫生系统面临的最大挑战之一。随着最近的技术进步，生物恐怖分子也有可能比病毒的自然进化更快地制造出潜在的大流行病毒株。因此，急需一种广谱的流感治疗/预防产品。我们已经确定了一种先导药物Fludase（TM），它针对所有流感毒株和亚型，包括潜在的大流行毒株。在第一阶段生物防御SBIR应用的资助下，我们已经证明了它对各种流感病毒的有效性。与目前可用的流感疫苗不同，Fludase（TM）不需要每年更新。Fludase（tm）的生产成本低，在自然流行病或生物战爆发时以及每年的流行病爆发时都可以随时获得。作为局部和局部施用的基于蛋白质的治疗剂，Fludase（TM）还可以潜在地避免与目前可用的昂贵的抗病毒化合物相关的副作用和产生耐药病毒的风险。本资助申请的目的是完成所有必要的临床前开发，并启动Fludase（TM）的早期临床开发。