Development of Fludase for Prevention of Influenza

预防流感的 Fludase 的开发

• 批准号: 6934932
• 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/6934932
• 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）：流感的特征是复发年度流行病和周期性的全球大流行病。由于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年中，有3种主要的流感大流行。自上次大流行以来大约三十年了。新的大流行被认为是迫在眉睫，这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，生物恐怖主义者也有可能比病毒的自然进化更快地产生潜在的大流行病毒菌株。因此，迫切需要一种针对流感的广谱治疗/预防性产物。我们已经确定了一种药物铅，氟藻酶（TM），该药物靶向包括潜在大流行菌株的所有菌株和亚型。随着I期生物Fense SBIR应用的资金，我们已经证明了其对各种流感病毒的功效。与当前可用的流感疫苗不同，Fludase（TM）无需每年更新。 Fludase（TM）可以有效地产生成本，并且可以在天然大流行或生物 - 战争开始时很容易获得，并用于年度流行病。作为局部和局部给药的基于蛋白质的治疗剂，Fludase（TM）也可以避免副作用和产生与当前可用昂贵的抗病毒化合物相关的耐药性病毒的风险。该赠款应用的目的是完成所有必要的临床前开发，并启动Fludase（TM）的早期临床发展。