Integrated CV-N Preclinical Clinical Microbicide Program

综合 CV-N 临床前临床杀菌剂项目

• 批准号: 6469434
• 负责人: Richard Bax
• 金额: $ 174.86万
• 依托单位: BIOSYN, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6469434
• 关键词: antiAIDS agent; clinical research; cooperative study; drug design /synthesis /production; human immunodeficiency virus 1; topical drug application

DESCRIPTION (provided by applicant): Enormous investments in AIDS related research and in public education have not been able to stem the worldwide pandemic. The consequences of this are most dire in developing parts of the world where transmission rates continue to increase at alarming rates, with women being particularly vulnerable to infection. Development of a protective vaccine is not likely in the short-term, thus the availability of alternative means of HIV infection prevention is critical. Effective microbicides administered vaginally may be an important means of prevention that have the further advantage of empowering women who are unable to negotiate condom use with the ability to protect themselves. This Program Project application is responsive to the stated objectives of announcement PA- 01-075; specifically, to advance development and optimization of lead topical microbicide candidates and to advance these microbicide candidates into pilot clinical studies. Biosyn, Inc. has assembled an outstanding team of scientists and drug development experts to specifically develop and advance cyanovirin-N (CV-N) as an anti-HIV topical microbicide. CV-N is one of the most interesting anti-HIV compounds available for microbicide development. Three separate research projects within the program will focus on: the production of CV-N protein in recombinant expression systems; the study of CVN formulation deployment in vitro and in vivo; and the feasibility of using CV-N in combination with other microbicide candidates as determined in an ex vivo system. These research projects will be supported by three cores which will be responsible for: administration and drug development; formulation, development; and virology testing. The iterative research and development efforts of these projects and cores will be a powerful means of rapidly and effectively advancing CV-N as an anti-HIV microbicide.

描述（由申请人提供）：与艾滋病相关的巨额投资 研究和公共教育无法阻止 全球大流行。这种后果在开发零件时最可怕 在以惊人的速度以惊人的速度上升的世界中 妇女特别容易感染。开发 保护性疫苗在短期内不太可能 预防HIV感染的替代手段至关重要。有效的 阴道施用的杀菌剂可能是预防的重要手段 具有增强无法 协商避孕套的使用，以保护自己的能力。这个程序 项目申请对公告的既定目标有响应 01-075;具体而言，要推进铅局部的开发和优化 候选菌心候选物，并将这些杀微生物候选物推向飞行员 临床研究。 Biosyn，Inc。组装了未偿还的 科学家和药物开发专家团队，专门发展和 将蓝黄酮-N（CV-N）作为抗HIV局部菌心。 CV-N是之一 最有趣的抗HIV化合物可用于杀菌剂的发育。 该计划中的三个独立的研究项目将重点关注： 重组表达系统中CV-N蛋白的产生； CVN的研究 体外和体内配方部署；以及使用的可行性 CV-N与其他在EX中确定 体内系统。这些研究项目将得到三个核心的支持 将负责：管理和药物开发；配方， 发展;和病毒学测试。迭代研究与发展 这些项目和核心的努力将是快速的强大手段，并且 有效地将CV-N作为抗HIV微生物剂前进。