Study of Vaginal Danazol on Endometriosis

Period of Performance: 09/30/1999 - 12/31/2000

Unknown

Phase 1 SBIR

Recipient Firm

Femme Pharma, Inc.
Wayne, PA 19087
Principal Investigator

Research Topics

Abstract

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.