NEW TOPICAL PROPHYLACTIC AGENT FOR GENITAL HERPES

描述（改编自申请）：申请人的新型有机金属抗病毒药物CTC 96 （Doxovir (TM)）在眼部疾病的细胞培养和动物模型中显示出对1型单纯疱疹病毒（HSV-1）的活性。与之密切相关的HSV-2，仅在美国就造成了4500万例生殖器疱疹感染，对动物模型中用作阴道杀菌剂的CTC-96敏感。CTC-96还能灭活人类免疫缺陷（艾滋病）病毒。没有fda批准的杀菌剂或疫苗可用于这两种疾病。研制一种CTC-96杀菌剂并对其进行测试以供妇女使用是这项二期SBIR申请的目标。将调查CTC-96对一系列性传播病原体的活性，以及它对精子和阴道健康的影响。配方将根据疗效、安全性和便利性进行设计和优化。CTC-96的摄取、处置和排泄将在动物中使用放射性标记材料进行测定。研究该药物的作用机制，有助于其他相关金属有机疗法的合理开发。作为SBIR项目的一部分，将寻求FDA的指导和批准进行初步临床试验。拟议的商业应用：该研究将阐明氧化还原~s抗疱疹剂（CTC-96; Doxovir (TM)）在预防生殖器疱疹和其他性传播疾病中的潜在用途。仅在美国，每年就有大约70万例原发性病例和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）也可用于口腔面部疱疹（每年约5000万例）和其他皮肤疱疹感染（如带状疱疹）。潜在市场包括全世界的传染病专家、皮肤科医生和全科医生及其患者。预防艾滋病的有效性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.