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QUATRX ANNOUNCES FURTHER POSITIVE PHASE 3 RESULTS FOR OPHENA (OSPEMIFENE TABLETS) IN POSTMENOPAUSAL VAGINAL ATROPHY[July 29, 2009] ANN ARBOR, MI— QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, today announced positive
top-line efficacy results from the first of two patient cohorts in its second pivotal Phase 3 trial of the investigational compound, Ophena
(ospemifene tablets), for the treatment of postmenopausal vulvovaginal atrophy (VVA). The Company has also successfully completed two long term safety
extension studies from its first pivotal Phase 3 studies. QuatRx intends to use these results in support of a New Drug Application (NDA) with the U.S. Food and
Drug Administration (FDA) in early 2010 seeking approval for Ophena a new SERM (selective estrogen receptor modulator) for the treatment of the
symptoms of vulvovaginal atrophy. Ophena™ is the only non-estrogen therapy currently in late-stage development for the treatment of vaginal symptoms
associated with menopause.
Phase 3 Long Term Safety Update In January 2008, QuatRx announced positive results from its first pivotal Phase 3 trial of Ophena. The Company has since completed two long term safety
extensions from this first Phase 3 trial. Women who had undergone a hysterectomy were enrolled in an open label study of 60mg Ophena for an
additional year of therapy. Women with an intact uterus were enrolled into an extension study where the treatment blind was maintained for a total of a year. In
this study, 83% of women taking 60mg of Ophena completed the study, compared with 69% of women on placebo. The most frequently occurring
treatment-emergent adverse event that was considered related to study drug was hot flush (7% in 60mg Ophena vs. 4% in placebo). Most
treatment-emergent adverse events were mild or moderate in severity. No trends were apparent in severe treatment-emergent adverse events and no cases of
pelvic organ prolapse, venous thromboembolism, endometrial hyperplasia or carcinoma were observed. Overall, the results of this double-blind,
placebo-controlled, long-term safety extension study demonstrated that daily doses of 60mg Ophena are well-tolerated in the treatment of
vulvovaginal atrophy.
About Postmenopausal Vaginal Atrophy Postmenopausal vulvovaginal 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 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. Current prescription treatments approved for this condition all contain estrogen, administered either orally or locally in the vagina. SERMs that are currently approved and marketed in the United States have not been shown to have beneficial effects on vaginal tissue and none are approved for use in treating vaginal atrophy 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 preclinical program. Fispemifene is a new selective estrogen receptor antagonist that is in Phase 2 studies as an oral treatment for the symptoms of secondary hypogonadism 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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