NEW TOPICAL PROPHYLACTIC AGENT FOR GENITAL HERPES

描述（根据申请改编）：申请人的新的有机金属抗病毒剂CTC 96（Doxovir（TM））已在细胞培养和眼病动物模型中证明了对单纯疱疹病毒1型（HSV-1）的活性。仅在美国就有4500万例生殖器疱疹感染病例是由与之密切相关的HSV-2引起的，它对在动物模型中用作阴道杀微生物剂的CTC-96敏感。CTC-96还可灭活人类免疫缺陷（艾滋病）病毒。没有FDA批准的杀微生物剂或疫苗可用于任何疾病。制定CTC-96杀微生物剂并测试其是否可供妇女使用是SBIR应用第二阶段的目标。将调查CTC-96对一系列性传播病原体的活性，以及其对精子和阴道健康的影响。将针对有效性、安全性和便利性设计和优化制剂。将使用放射性标记材料在动物中测定CTC-96的摄取、处置和排泄。探讨其作用机制，为合理开发其他相关的金属有机治疗药物提供参考。将寻求FDA的指导和批准进行初始临床试验，该试验将作为SBIR计划的一部分进行。拟定商业应用：这项研究将阐明Redox抗疱疹剂（CTC-96; Doxovir（TM））在预防生殖器疱疹和其他性病方面的潜在用途。仅在美国，每年就有大约70万例原发病例和2000万例复发病例。抗疱疹药物阿昔洛韦的全球年销售额超过10亿美元。Doxovir（TM）也可用于口面疱疹（每年约50，000，000例）和其他皮肤疱疹感染（例如，带状疱疹）。 潜在的市场包括传染病专家、皮肤科医生和全科医生以及他们的病人。有效预防艾滋病将大大扩大市场需求。

DESCRIPTION (Adapted from the application): The applicant~s new organometallic antiviral, CTC 96 (Doxovir (TM)) has demonstrated activity against herpes simplex virus type 1 (HSV-1) in cell culture and animal models of ocular disease. The closely related HSV-2, which is the cause of 45 million cases of genital herpes infection in the U.S. alone, is sensitive to CTC-96 used as a vaginal microbicide in animal models. CTC-96 also inactivates human immunodeficiency (AIDS) virus. No FDA-approved microbicide or vaccine is available for either disease. Formulating a CTC-96 microbicide and testing it for use by women is the goal of this Phase II SBIR application. CTC-96 activity against a range of sexually transmitted pathogens will be surveyed, as will its effects on sperm and vaginal health. Formulations will be designed and optimized for efficacy, safety, and convenience. Uptake, disposition, and excretion of CTC-96 will be determined using radio labeled material in animals. The agent~s mechanism of action will be investigated to facilitate rational development of other related metallo-organic therapeutics. FDA guidance and approval will be sought for initial clinical testing, which will be conducted as part of this SBIR program. PROPOSED COMMERCIAL APPLICATION: The research will clarify the potential use of Redox~s antiherpetic agent (CTC-96; Doxovir (TM)) for prevention of genital herpes and other STDs. There are about 700,000 primary cases and 20 million recurrences annually in the US alone. Yearly worldwide sales of the leading antiherpetic drug, acyclovir, exceed $1 billion. Doxovir (TM) could also be used for orofacial herpes (about 50,000,000 cases per year) and other dermal herpes infections (e.g., shingles). Potential markets include infectious disease specialists, dermatologists and general practitioners world-wide and their patients. Efficacy in preventing AIDS would significantly extend market demand.