NEW TOPICAL PROPHYLACTIC AGENT FOR GENITAL HERPES

氧化还原制药公司的新型抗病毒和抗炎药物 金属有机化合物CTC 96(DoxovirTM)已显示出活性 细胞培养和动物体内抗单纯疱疹病毒1型的实验研究 眼部疾病的模型。与之密切相关的HSV-2，这就是原因 仅在美国就有4500万生殖器疱疹感染病例， 在动物模型和培养细胞中进行研究。在预赛中 实验表明，CTC 96预防性治疗完全可以预防 病毒在小鼠阴道内的复制或疾病的发展 一条小路。这个实验将在豚鼠身上重复，这表明 生殖器疱疹更接近于模拟人类疾病。两种动物都是 模型将被用来确定剂量依赖和时间依赖 最佳的预防效果。用实验来确定 CTC 96的作用部位是病毒、宿主细胞或某些产物 病毒感染将在纯化的病毒和培养的病毒上进行 细胞。氧化还原公司打算研制一种抗疱疹阴道杀菌剂 并寻求FDA批准人类临床试验(IND)作为 第二阶段SBIR应用。 建议的商业应用： 这项研究将阐明Redox抗疱疹药物的潜在用途 用于预防生殖器疱疹的试剂(CTC 96；DoxovirTM)。确实有 每年约有70万例初发病例和2000万例复发 只有我们两个。全球领先的抗疱疹药物的年销售量， 阿昔洛韦，超过10亿美元。DoxovirTM还可以用于 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 传染病专家、皮肤科医生和全科医生 以及他们的病人。

Redox Pharmaceutical Corporations's new antiviral and anti- inflammatory metallo-organic compound, CTC 96 (DoxovirTM) 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 US alone, will be studied in animal models and cultured cells. In preliminary experiments, prophylactic treatment with CTC 96 completely prevented replication of virus or development of disease in the mouse vaginal tract. This experiment will be repeated in guinea pigs, which manifest genital herpes more closely modeling the human disease. Both animal models will be used to determine the dose-dependence and time-dependence of optimal prophylactic efficacy. Experiments to determine whether the CTC 96 site of action is the virus, the host cell, or some product of viral infection will be carried out on purified virus and on cultured cells. Redox intends to formulate an anti-herpetic vaginal microbicide and pursue FDA approval for human clinical testing (IND) as part of a phase II SBIR application. PROPOSED COMMERCIAL APPLICATION: This research will clarify the potential use of Redox's antiherpetic agent (CTC 96; DoxovirTM) for prevention of genital herpes. 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 dollars. DoxovirTM 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.