EVALUATION OF A 24 HOUR MICROBICIDE VAGINAL SUPPOSITORY

24 小时杀菌阴道栓剂的评价

• 批准号: 6016852
• 负责人: ELIE NUWAYSER
• 金额: $ 18.88万
• 依托单位: BIOTEK, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2001-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6016852
• 关键词: Herpes simplex disease; chlamydial disease; disease /disorder model; dosage forms; drug screening /evaluation; guinea pigs; microorganism disease chemotherapy; nonhuman therapy evaluation; nonoxynol 9; sexually transmitted diseases; swine; topical drug application

BIOTEK developed under NICHD Contract N01-HD-l2829 and SBIR Grant No. 2R44HD28387-02, a bioerodible contraceptive suppository which delivers an immediate dose of the spermicide nonoxynol-9 within one minute after insertion, followed by a sustained dose of nonoxynol-9 for a period of 24 hours. The suppository has been extensively tested in vitro, ex vivo with both rabbit and human semen, in vivo in rabbits, and clinically on 14 women using postcoital tests (PCT) in which the suppository was inserted l2 hours before intercourse. The PCT tests were conducted at two clinical centers. None of the l4 women showed any live sperm in the vagina in the 12 hour PCT test. Details of the in vitro, ex vivo, in vivo and clinical tests are presented in the proposal. The data to date shows that the composite suppository is effective for a period of at least l2 hours. Evaluation of its performance beyond this period is currently underway in a PCT study in which the suppository is inserted 24 hours before intercourse. The results of this study will not become available for six to nine months. Given the fact that nonoxynol-9 is effective both as a spermicide and microbicide against sexually transmitted diseases (STD's), support is sought for a Phase I study to test the efficacy of the suppository as a microbicide. Specifically, we would like to test its ability to inactivate STD pathogens with the time of pretreatment extended over periods up to 12 hours following insertion into the vagina. These tests will be conducted in an animal model developed by Dr, Nigel Bourne and Dr. David Bernstein at the Children's Hospital Medical Center, Cincinnati, Ohio. The animal models are: the guinea pig model of genital herpes simplex virus (HSV-2) and the guinea pig chlamidyal infection model. PROPOSED COMMERCIAL APPLICATIONS: It is currently estimated that 10 million people have genital HSV-2 infections and 500,000 new cases are identified yearly. The most common STD in the U.S. is chlamydiosis which can lead to a number of serious complications. There is an urgent need for an unobtrusive method by which a woman can protect herself against STD's without active cooperation of her male partner. Thus, it is clear that the potential market for a product that will protect against STD's is very significant.

BIOTEK根据NICHD合同N01-HD-l2829和SBIR授权号2R44HD28387-02开发了一种生物可溶避孕栓剂，在插入后一分钟内立即提供剂量的杀精剂nonoxynol-9，随后持续剂量的nonoxynol-9持续24小时。该栓剂已在体外、体外用兔和人精液、体内用兔进行了广泛的试验，并在14名妇女身上进行了临床试验，使用性交前12小时插入栓剂进行了性交后试验。PCT试验在两个临床中心进行。在12小时的PCT测试中，14名女性都没有发现阴道内有活精子。建议中详细介绍了体外、离体、体内和临床试验。迄今为止的数据表明，复合栓剂的有效时间至少为12小时。目前正在一项PCT研究中评估其在此期间之后的性能，其中栓剂在性交前24小时插入。这项研究的结果将在6到9个月内公布。鉴于壬苯醇醚-9作为杀精剂和杀微生物剂对性传播疾病（STD）都是有效的，因此寻求I期研究的支持，以测试栓剂作为杀微生物剂的功效。具体来说，我们想测试其灭活性病病原体的能力，在插入阴道后的预处理时间延长至12小时。这些测试将在一个动物模型中进行，该模型是由俄亥俄州辛辛那提儿童医院医学中心的奈杰尔·伯恩博士和大卫·伯恩斯坦博士开发的。动物模型为：单纯疱疹病毒（HSV-2）豚鼠模型和豚鼠衣原体感染模型。拟议的商业应用：目前估计有1000万人患有生殖器2型单纯疱疹病毒感染，每年发现50万新病例。在美国最常见的性病是衣原体病，它会导致许多严重的并发症。迫切需要一种不引人注目的方法，使妇女在没有男性伴侣积极合作的情况下保护自己免受性病的侵害。因此，很明显，一种预防性病的产品的潜在市场是非常重要的。