Navigation Links
QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome
Date:8/22/2007

Multicenter Study Enrolls More Than 800 Women to Evaluate QuatRx's

New-Generation Selective Estrogen Receptor Modulator (SERM)

ANN ARBOR, Mich., Aug. 22 /PRNewswire/ -- 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.


'/>"/>
SOURCE QuatRx Pharmaceuticals Company
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Lev Pharmaceuticals Completes Phase III Prophylaxis Trial of C1-Esterase Inhibitor for Hereditary Angioedema
2. Celsion Completes Enrollment in Phase I Liver Cancer Study
3. LANI completes Phase I in Japan and to commence Phase I in UK
4. Ace Biosciences, Ace393, the Worlds First Commercial Vaccine for Travellers Diarrhoea Caused by Campylobacter Successfully Completes Phase I Clinical Trials
5. Monitoring Patient Glucose Levels: New Advances in software make it easier
6. Managing Preanalytical Processes for Patient Safety
7. Hematology Analyzers Simple, Sophisticated Technology Serving All Patients
8. Near-Patient Testing: The Advantages of C-Reactive Protein in Hematological Testing
9. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
10. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
11. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... , Oct. 12, 2017   Divoti USA ... Jewelry up to the standard of the latest FDA requirements, which ... 2017). Anyone in need of Medical ID jewelry such ... Alert Jewelry are engraved in terms of the new ... Divoti offers ...
(Date:10/11/2017)... 2017  True Health, a leader in integrated ... during National Breast Cancer Awareness month to educate ... Research recently published ... more than 10 million American women are at ... or BRCA2 and have not had testing. These mutations ...
(Date:10/7/2017)... , Oct. 6, 2017   Provista, a ... than $100 billion in purchasing power, today announced a ... information. The Newsroom is the online home ... trends, infographics, expert bios, news releases, slideshows and events. ... to a wealth of resources at their fingertips, viewers ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... 2017 , ... Dr. Parsa Mohebi, the Los Angeles based ... the newly revamped Cosmetic Town journal section, featuring articles written by ... as Follicular Unit Extraction (FUE). , Dr. Mohebi says “I enjoy ...
(Date:10/12/2017)... ... ... Leading pediatric oncology experts at Children’s National Health System will join ... International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by Jeffrey Dome, ... at Children’s National, and Stephen P. Hunger, M.D., Chief of the Division of ...
(Date:10/12/2017)... RAPIDS, Mich. (PRWEB) , ... October 12, 2017 ... ... Wellness, has been named one of Michigan’s 2017 Best and Brightest in Wellness® ... and Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... property taxes a year. In some states—like New York, New Jersey, Massachusetts, Texas, ... many overseas retirement havens have extremely low property-tax rates, which contributes to the ...
(Date:10/12/2017)... Washington, D.C. (PRWEB) , ... October 12, 2017 ... ... Company, Cal Dining at the University of California Berkeley, and other leading institutions ... leverages the buying power of institutions to change the way animals are raised ...
Breaking Medicine News(10 mins):