Development of Fludase for Prevention of Influenza

描述（由申请人提供）：流感的特点是年度反复流行和周期性的全球性大流行。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。过去100年里，发生过3次重大流感大流行。距离上次大流行已经过去了大约三十年。一场新的大流行被认为迫在眉睫，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，生物恐怖分子也有可能比病毒自然进化的速度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 Fludase(tm)，它针对流感的所有毒株和亚型，包括潜在的大流行毒株。在第一阶段 Biodefense SBIR 申请的资助下，我们已经证明了它对多种流感病毒的功效。与目前可用的流感疫苗不同，Fludase(tm) 不需要每年更新。 Fludase(tm) 的生产成本低廉，并且可以在自然流行病或生物战爆发时以及每年的流行病中轻松获得。作为一种基于蛋白质的局部治疗剂，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。本次拨款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。

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).