Development of Fludase for Prevention of Influenza

预防流感的 Fludase 的开发

• 批准号: 7275450
• 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 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7275450
• 关键词: Address; Adverse effects; Animal Model; Antiviral Agents; Applications Grants; Canis familiaris; Clinical; Data; Development; Disease; Dose; Drug Formulations; Economics; Epidemic; Evolution; Eye; Ferrets; Frequencies; Funding; Grant; Health system; Human; Influenza; Influenza Therapeutic; Influenza prevention; Inhalant dose form; Investigational Drugs; Investigational New Drug Application; Lead; Metered Dose Inhaler Device; Modeling; Molecular; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Oryctolagus cuniculus; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Process; Production; Prophylactic treatment; Proteins; Public Health; Range; Rattus; Recombinant Proteins; Recurrence; Risk; Safety; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Staging; Surface; Therapeutic; Therapeutic Agents; Time; Today; Toxic effect; United States Food and Drug Administration; Update; Vaccines; Viral; Virus; Work; airway epithelium; base; biodefense; cost; drug resistant virus; immunogenicity; influenza virus strain; influenza virus vaccine; influenzavirus; mortality; novel; pandemic disease; pandemic influenza; pre-clinical; prophylactic; receptor; tissue culture

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）：流感的特点是每年复发性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高，流感的直接和间接社会经济影响巨大。在过去的100年里，发生了三次主要的流感大流行。距离上次大流行已经过去了大约30年。一场新的大流行被认为迫在眉睫，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潜在的大流行病毒株。因此，迫切需要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fluudase (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申请的资助下，我们已经证明了它对多种流感病毒的有效性。与目前可用的流感疫苗不同，fluudase （tm）不需要每年更新。fluudase （tm）的生产具有成本效益，可在自然大流行或生物战开始时随时获得，并可用于年度流行病。作为一种局部和局部使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fluudase （tm）的早期临床开发。

项目成果

Novel pandemic influenza A(H1N1) viruses are potently inhibited by DAS181, a sialidase fusion protein.

• DOI: 10.1371/journal.pone.0007788
• 发表时间: 2009-11-06
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Triana-Baltzer GB;Gubareva LV;Nicholls JM;Pearce MB;Mishin VP;Belser JA;Chen LM;Chan RW;Chan MC;Hedlund M;Larson JL;Moss RB;Katz JM;Tumpey TM;Fang F
• 通讯作者: Fang F