ANN ARBOR, Mich., Aug. 22 QuatRx Pharmaceuticals, aprivately-held biopharmaceutical company focused on development andcommercialization of compounds to treat endocrine, metabolic andcardiovascular disorders, today announced that it has completed enrollment ofa pivotal Phase 3 clinical trial of Ophena(TM) (ospemifene), the company'sestrogen-free oral therapy in development for the treatment of vaginalsymptoms associated with menopause.
Ophena(TM) is a new-generation selective estrogen receptor modulator(SERM) for postmenopausal vaginal syndrome (PVS), a common condition inpostmenopausal women sometimes referred to as vaginal atrophy andcharacterized by vaginal symptoms such as dryness, irritation and sexual pain.Phase 2 clinical trials with Ophena(TM) demonstrated beneficial effects onvaginal epithelium and bone markers. In addition, in a Phase 2 trial,Ophena(TM) did not induce hot flashes in postmenopausal women when compared toplacebo.
Patient enrollment for the randomized, double-blind study has reached 827post-menopausal women at 80 trial centers throughout the United States. Womenparticipating in the study are treated with either a 30- or 60-mg once dailyoral dose of Ophena(TM) or placebo for 12 weeks. The study is the first oftwo pivotal Phase 3 efficacy trials planned for the compound.
"Completion of enrollment for this first Ophena(TM) Phase 3 trial is asignificant development milestone," said Robert L. Zerbe, M.D., chiefexecutive officer and president of QuatRx. "In this pivotal study we areseeking to confirm the beneficial vaginal effects already seen in our Phase 2program. Millions of women suffer from such post-menopausal symptoms forwhich there are no oral non-estrogen treatments available. Ophena(TM) isspecifically designed to address a major unmet need for women and forphysicians seeking alternatives to hormone therapies."
Dr. Alan Altman, Assistant Clinical Professor of Obstetrics, Gynecology,and Reproductive Biology, Harvard Medical School and an expert on menopause,commented "Physicians are now seeing an epidemic of vaginal symptoms, such asdryness, irritation and sexual pain, in post-menopausal patients as a resultof large numbers of women stopping hormone treatment due to fear instilled bywhat they have read about the Women's Health Initiative Study. Chronicsymptoms such as these have a major adverse impact on quality of life forthese women and highlight the need for new treatment options in those wantingto avoid estrogen use."
About Postmenopausal Vaginal Syndrome
Postmenopausal Vaginal Syndrome (PVS) is a chronic condition characterizedby vaginal symptoms including dryness, sexual pain (dyspareunia), andirritation. Declining estrogen levels during menopause may cause tissues ofthe vaginal lining to grow thinner and to lose elasticity, a condition knownas atrophy. Dryness and irritation associated with decreases in vaginalsecretions often cause pain or bleeding during sexual intercourse. Thedecline in estrogen also contributes to an increase in vaginal pH, creating anenvironment more susceptible to infection. There are more than 64 millionwomen in the United States who are over 40 years old. It is estimated that upto 40% of post-menopausal women will have symptoms of PVS. Current treatmentsapproved for this condition all contain estrogen, administered either orallyor locally in the vagina. Other currently available SERMs do not have aneffect on vaginal tissue and may induce hot flashes.
QuatRx Pharmaceuticals is focused on the discovery, licensing, developmentand commercialization of compounds in the endocrine, metabolic andcardiovascular therapeutic areas. In addition to Ophena(TM), QuatRx has threeother product candidates in active clinical development and two preclinicaldevelopment programs. Fispemifene is a new, selective estrogen receptorantagoni