QuatRx Completes Patient Enrollment In Phase 3 Study Of Ophena(TM) In Women With Postmenopausal Vaginal Syndrome

Main Category: Women's Health / Gynecology
Also Included In: Endocrinology;  Clinical Trials / Drug Trials
Article Date: 23 Aug 2007 - 0:00 PDT

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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 need for women and for physicians 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 as dryness, irritation and sexual pain, in post-menopausal patients as a result of large numbers of women stopping hormone treatment due to fear instilled by what they have read about the Women's Health Initiative Study. Chronic symptoms such as these have a major adverse impact on quality of life for these women and highlight the need for new treatment options in those wanting to avoid estrogen use."

About Postmenopausal Vaginal Syndrome

Postmenopausal Vaginal Syndrome (PVS) is a chronic condition characterized by vaginal symptoms including dryness, sexual pain (dyspareunia), and irritation. Declining estrogen levels during menopause may cause tissues of the vaginal lining to grow thinner and to lose elasticity, a condition known as atrophy. Dryness and irritation associated with decreases in vaginal secretions often cause pain or bleeding during sexual intercourse. The decline in estrogen also contributes to an increase in vaginal pH, creating an environment more susceptible to infection. There are more than 64 million women in the United States who are over 40 years old. It is estimated that up to 40% of post-menopausal women will have symptoms of PVS. Current treatments approved for this condition all contain estrogen, administered either orally or locally in the vagina. Other currently available SERMs do not have an effect on vaginal tissue and may induce hot flashes.

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(TM), QuatRx has three other product candidates in active clinical development and two preclinical development programs. 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. QRX-431, a novel, selective thyroid receptor beta agonist, is in Phase 1 studies as a potential treatment for lipid disorders and obesity. Becocalcidiol, a novel Vitamin D analogue, is in Phase 2 clinical trials for the treatment of psoriasis and was recently licensed to CollaGenex Pharmaceuticals, Inc. for continued development and commercialization. QuatRx's two preclinical small molecule programs are designed to address common endocrine disorders in women. For press releases and other Company information, please visit http://www.quatrx.com.

QuatRx Pharmaceuticals Company
http://www.quatrx.com