Bolken T C, Hruby D E
SIGA Technologies, Inc., Corvallis, OR 97333, USA.
Drugs Today (Barc). 2010 Feb;46(2):109-17. doi: 10.1358/dot.2010.46.2.1437244.
SIGA Technologies, Inc. is a small biotech company committed to developing novel products for the prevention and treatment of serious viral diseases, with an emphasis on products to combat outbreaks that could result from bioterrorism. With government support, SIGA has developed the necessary infrastructure to successfully advance new antiviral drugs from the discovery stage through to licensing. Currently, there is a need to develop safe and effective inhibitors for poxvirus-induced diseases such as smallpox caused by variola, which is a potential biological warfare agent. Likewise emerging zoonotic infections due to cowpox virus and monkeypox virus require the development of effective countermeasures. Tecovirimat, also known as ST-246, has shown efficacy in all small animal and nonhuman primate prophylaxis and therapeutic efficacy models of poxvirus-induced disease tested to date. Phase I clinical trials and new drug application-enabling toxicology studies have been completed with tecovirimat. A phase II clinical study is being run and SIGA has initiated commercial scale-up manufacturing and preparation for the pivotal safety and efficacy studies. SIGA is committed to getting approval for tecovirimat and supplying it to the Strategic National Stockpile, the Department of Defense and global health authorities.
SIGA科技公司是一家小型生物技术公司,致力于开发用于预防和治疗严重病毒性疾病的新型产品,尤其侧重于开发应对可能由生物恐怖主义引发的疫情的产品。在政府的支持下,SIGA已建立了必要的基础设施,能够成功地将新型抗病毒药物从发现阶段推进到许可阶段。目前,需要开发安全有效的抑制剂来治疗痘病毒引起的疾病,如由天花病毒引起的天花,天花病毒是一种潜在的生物战剂。同样,由牛痘病毒和猴痘病毒引起的新发人畜共患病感染也需要开发有效的应对措施。替考韦瑞玛,也称为ST - 246,在迄今为止测试的所有痘病毒引起疾病的小动物和非人类灵长类动物预防及治疗效果模型中均显示出疗效。替考韦瑞玛已完成I期临床试验和支持新药申请的毒理学研究。正在进行II期临床研究,SIGA已启动商业规模扩大生产,并为关键的安全性和有效性研究做准备。SIGA致力于使替考韦瑞玛获得批准,并将其供应给国家战略储备、国防部和全球卫生当局。