STUDY OF VAGINAL DANAZOL ON ENDOMETRIOSIS

FemmePharma，Inc.，一家致力于开发妇女产品的新公司提议在猴子身上进行可行性研究，以确定一种获得专利的、重要的子宫内膜异位症新疗法的适当剂量和安全性，子宫内膜异位症是妇女的一种常见疾病，治疗选择很少，而且无法接受。 目前的治疗选择导致显著和不可接受的副作用，通常将其使用限制为几个月的治疗。Femmepharma的新疗法可以为这种疾病创造一种新的高效治疗方法，副作用很少。拟议的研究是一项在患有子宫内膜异位症的恒河猴（TMcacca mulatta）中进行的先导性、随机化、剂量递增、安慰剂和阳性对照研究，随后将在女性中进行研究。猴将接受FemmePharma专有治疗，并与口服达那唑进行比较。 在整个研究期间，将记录拟定治疗对恒河猴临床症状和行为变化的影响，并将其分级作为主要临床终点。 次要终点将包括评价子宫内膜种植体和子宫内膜活检，以确定组织学变化。 将进行阴道检查和阴道涂片，以记录局部影响。 该研究将在威斯康星州区域灵长类动物研究中心全面进行。建议的商业应用这可能导致一种治疗患有子宫内膜异位症的妇女的新方法，其具有改善的功效和减少的副作用。 通过扩大对治疗人群的渗透，我们相信这将具有非常重要的商业价值;收入超过1亿美元。

FemmePharma, Inc., a new company devoted to developing products for women, proposes to conduct a feasibility study in monkeys to determine the appropriate dose and safety of a patented, and significant new therapy for endometriosis, a common disease of women with few and unacceptable treatment options. Present treatment options result in significant and unacceptable side effects, often limiting their use to a few months of therapy. Femmepharma's new therapy could create a new and highly effective treatment for this disease with few side effects. The proposed study is a pilot, randomized, ascending-dose, placebo and positive controlled study, in rhesus monkeys (TMcacca mulatta) with endometriosis and will be followed by studies in women. The monkeys will be administered FemmePharma's proprietary treatment and compared to oral danazol. The effect of the proposed treatments on clinical symptoms and behavioral changes suffered by the rhesus monkeys will be recorded and graded throughout the study as primary clinical end points. Secondary end points will include evaluation of endometrial implants, and endometrial biopsies to determine histological changes. Vaginal examination and vaginal smears will be done to record local effects. The study will be conducted in its entirety at the Wisconsin Regional Primate Research Center. PROPOSED COMMERCIAL APPLICATION This may result in a novel method of treatment of women suffering from endometriosis with improved efficacy, and a reduction in side effects. By expanding penetration into the treated population we believe that the commercial value of this to be very significant; revenues greater than 100 million dollars.