ANN ARBOR, Mich., Feb. 16 /PRNewswire/ -- QuatRx Pharmaceuticals Company, a pharmaceutical company focused on discovering, licensing, developing and commercializing compounds in the endocrine, metabolic and cardiovascular therapeutic areas, today announced the initiation of a phase II clinical trial for fispemifene, the company's product candidate for the treatment of the symptoms of andropause, and the start of dosing in a phase III clinical trial of ospemifene, the company's product candidate for the treatment of post- menopausal vaginal atrophy.
Fispemifene Advances into Phase II
Fispemifene is the company's product candidate for the treatment of the symptoms of andropause. This first randomized, double-blind, placebo-controlled, parallel group phase II study of fispemifene in the treatment of low testosterone in older men will seek to enroll approximately 100 patients at approximately 20 study sites in the United States. Patients will receive either 100, 200, or 300 mg fispemifene or placebo for 28 days.
About Andropause
Andropause is a condition in men caused by a gradual decline in testosterone levels that occurs naturally as men age. The symptoms of andropause include muscle wasting, enlarged breasts, urinary tract problems and sexual dysfunction. Patients receiving treatment for andropause typically utilize testosterone replacement therapy. Unlike testosterone replacement therapies that are typically topical or injection therapies, fispemifene is an oral treatment and is not a formulation of testosterone. Rather, fispemifene utilizes the body's normal feedback mechanism to increase testosterone levels.
Ospemifene Phase III Dosing Commences
QuatRx also announced that dosing has commenced in its recently initiated first phase III clinical study of ospemifene. This phase III clinical trial of ospemifene is a randomized, double-blind, placebo-controlled, parallel group pivotal study of ospemifene in the treatment of vaginal atrophy. The company expects to enroll approximately 800 post-menopausal women in this study at approximately 65 study sites in the United States. Patients will receive 30 or 60 mg of ospemifene or placebo for 12 weeks. Following the treatment phase of the study, patients will be eligible to participate in a one-year extension study.
Ospemifene is a selective estrogen receptor modulator, or SERM, an orally available small molecule that binds to estrogen receptors and selectively stimulates or blocks estrogen's activity in different tissue types.
About Vaginal Atrophy
Vaginal atrophy is a common, chronic condition of post-menopausal women and is characterized by vaginal dryness, burning, irritation, itching, vaginal discharge and feeling of pressure. Associated urinary symptoms can include urinary frequency, pain on urination, urinary tract infections and incontinence.
Richard Fox Joins Board of Directors
QuatRx also announced today that Richard P. Fox has joined the company's board of directors. Mr. Fox has served as a consultant and outside board member to entrepreneurs and the financial services industry. Previously, Mr. Fox was president and chief operating officer of CyberSafe Corporation, an IT security company. Mr. Fox spent 28 years with Ernst & Young, last serving as Managing Partner of the Seattle office. He serves on the board of directors of Premera, a Blue Cross managed care provider, aQuantive, an online marketing company, Flow International, a machine tool manufacturer, Isothermal Systems, and Shurgard Storage Centers, Inc., a real estate investment trust. Mr. Fox will serve on the Audit Committee of the QuatRx board of directors.
About QuatRx
QuatRx is a pharmaceutical company focused on discovering, licensing, developing and commercializing compounds in the endocrine, metabolic and cardiovascular therapeutic areas. QuatRx, founded in 2000, is headquartered in Ann Arbor, Michigan and has operations in Europe through Hormos Medical Oy, a wholly owned subsidiary located in Turku, Finland.
QuatRx Pharmaceuticals CompanyCONTACT: Bill Berry of Berry & Company Public Relations for QuatRxPharmaceuticals Company, +1-212-253-8881, bberry@berrypr.com
