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QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome
Date:8/22/2007

Multicenter Study Enrolls More Than 800 Women to Evaluate QuatRx's

New-Generation Selective Estrogen Receptor Modulator (SERM)

ANN ARBOR, Mich., Aug. 22 /PRNewswire/ -- QuatRx Pharmaceuticals, a privately-held biopharmaceutical company focused on development and commercialization of compounds to treat endocrine, metabolic and cardiovascular disorders, today announced that it has completed enrollment of a pivotal Phase 3 clinical trial of Ophena(TM) (ospemifene), the company's estrogen-free oral therapy in development for the treatment of vaginal symptoms associated with menopause.

Ophena(TM) is a new-generation selective estrogen receptor modulator (SERM) for postmenopausal vaginal syndrome (PVS), a common condition in postmenopausal women sometimes referred to as vaginal atrophy and characterized by vaginal symptoms such as dryness, irritation and sexual pain. Phase 2 clinical trials with Ophena(TM) demonstrated beneficial effects on vaginal epithelium and bone markers. In addition, in a Phase 2 trial, Ophena(TM) did not induce hot flashes in postmenopausal women when compared to placebo.

Patient enrollment for the randomized, double-blind study has reached 827 post-menopausal women at 80 trial centers throughout the United States. Women participating in the study are treated with either a 30- or 60-mg once daily oral dose of Ophena(TM) or placebo for 12 weeks. The study is the first of two pivotal Phase 3 efficacy trials planned for the compound.

"Completion of enrollment for this first Ophena(TM) Phase 3 trial is a significant development milestone," said Robert L. Zerbe, M.D., chief executive officer and president of QuatRx. "In this pivotal study we are seeking to confirm the beneficial vaginal effects already seen in our Phase 2 program. Millions of women suffer from such post-menopausal symptoms for which there are no oral non-estrogen treatments available. Ophena(TM) is specifically designed to address a major unmet
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SOURCE QuatRx Pharmaceuticals Company
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