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QUATRX COMPLETES ENROLLMENT OF OPHENA (OSPEMIFENE TABLETS) FINAL PIVOTAL PHASE 3 STUDY IN WOMEN WITH POSTMENOPAUSAL VAGINAL ATROPHY[March 31, 2009] ANN ARBOR, MI— QuatRx Pharmaceuticals, a privately-held biopharmaceutical company, today announced that it has completed
enrollment in the Company’s second pivotal Phase 3 clinical trial of Ophena (ospemifene tablets). Together with the previously completed first pivotal
Phase 3 study of Ophena, the Company has fully enrolled its planned pivotal Phase 3 studies for Ophena, the most advanced
estrogen-free oral therapy currently in development for the treatment of vaginal symptoms associated with menopause. A total of more than 1,700 patients were
enrolled in these two pivotal studies at sites across the U.S. In accordance with the study design, all enrolled patients have received their first dose of either
Ophena or placebo in the second Phase 3 clinical trial. Due to the high level of interest from patients and physicians, the Company chose to exceed
its enrollment target of 750 patients. The Company expects to complete the study in late summer-2009 and these data, together with results from the first phase 3
study, will complete the efficacy requirements for an NDA filing under the published FDA guidance for vaginal atrophy.
About Postmenopausal Vaginal Atrophy Postmenopausal vaginal atrophy is a chronic and progressive condition characterized by symptoms including vaginal dryness, sexual pain (dyspareunia) and irritation. Declining estrogen levels during menopause can cause tissues of the vaginal lining to grow thinner and to lose elasticity, a condition known as vaginal atrophy. Dryness and irritation associated with reductions in vaginal secretions often cause pain or bleeding during sexual intercourse. It is estimated that 45-75 percent of postmenopausal women experience chronic symptoms of vaginal atrophy which are bothersome in over 90 percent of cases. Current prescription treatments approved for this condition all contain estrogen, administered either orally or locally in the vagina. No SERMs that are currently approved and marketed in the United States have been shown to have beneficial effects on vaginal tissue and none are approved for use in treating vaginal symptoms. About QuatRx QuatRx Pharmaceuticals is focused on the discovery, licensing, development and commercialization of compounds in the endocrine, metabolic and cardiovascular therapeutic areas. In addition to Ophena, QuatRx has three other product candidates in clinical development and an advanced preclinical program. Fispemifene is a new selective estrogen receptor antagonist that is in Phase 2 as an oral treatment for the symptoms of secondary hypogonadism and other conditions in men. Sobetirome, a novel, selective thyroid receptor beta agonist, is in Phase 1 as a potential treatment for dyslipidemia. Becocalcidiol, a novel Vitamin D analogue, is in Phase 2 clinical trials for the treatment of psoriasis through QuatRx’s partner, Galderma. QuatRx’s preclinical program is designed to address sex steroid dependent diseases through inhibition of 17beta-HSD enzymes. In Europe, QuatRx operates through its Finnish subsidiary, Hormos Medical Ltd, located in Turku, Finland. For press releases and other Company information, please visit www.quatrx.com.
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© 2008 QuatRx Pharmaceuticals Company Terms of Use |
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