EVALUATION OF A 24 HOUR MICROBICIDE VAGINAL SUPPOSITORY

Biotek是根据NICHD合同N01-HD-12829和SBIR授予编号2R44HD28387-02开发的，这是一种可生物侵蚀的避孕栓，在插入后一分钟内立即给药，然后持续给药24小时。该栓剂已在体外、体外与兔和人精液、在兔体内进行了广泛的测试，并在14名女性身上进行了临床试验(PCT)，其中在性交前12小时将该栓剂插入其中。PCT测试是在两个临床中心进行的。在12小时的PCT测试中，L4女性中没有一人在阴道中显示出任何活精子。该提案介绍了体外、体外、体内和临床试验的详细情况。到目前为止的数据表明，该复方栓剂的有效期至少为12小时。目前正在进行一项PCT研究，在性交前24小时插入栓剂，以评估其在这段时间后的表现。这项研究的结果将在六到九个月内公布。鉴于壬醇-9作为杀精剂和杀微生物剂对性传播疾病(STD)都有效的事实，人们寻求支持进行一项第一阶段研究，以测试该栓剂作为杀微生物剂的效果。具体地说，我们希望测试其灭活性病病原体的能力，将预处理时间延长至插入阴道后长达12小时。这些测试将在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中进行。动物模型为：豚鼠生殖器单纯疱疹病毒(HSV-2)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HSV-2感染，每年发现50万新病例。在美国，最常见的性传播疾病是衣原体病，它会导致一些严重的并发症。迫切需要一种不引人注目的方法，使女性能够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袭。因此，很明显，一种能够预防性病的产品的潜在市场是非常重要的。

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.