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:2/5/2016)... , Feb. 5, 2016  Aralez Pharmaceuticals Inc. ... of POZEN Inc. ("POZEN") and Tribute Pharmaceuticals Canada Inc. ("Tribute") ... and shareholders of Tribute. The combined company will operate ... company with operations in Canada , ... United States . Under the terms of the ...
(Date:2/5/2016)... February 5, 2016 --> ... report states that the global active pharmaceuticals ingredients (APIs) ... predicted to reach US$185.9 bn by 2020. It is ... 2014 to 2020. The title of the report is ... by Geography, and by Therapeutic Area) - Global Industry ...
(Date:2/5/2016)... Feb. 5, 2016  Henry Schein, Inc. (NASDAQ: HSIC ... and services to office-based dental, animal health and medical ... agreement to acquire a majority ownership interest in Dental ... in Brazil . ... Dental Cremer is the dental distribution business of Cremer ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... The event is being ... Block Event Center in Minneapolis, Minn. Triumph Over Parkinson’s will fund nearly $100,000 for ... of Schneiderman’s Furniture, lives with Parkinson’s disease and is the architect of this informative ...
(Date:2/5/2016)... ... , ... After years as an active staff surgeon and having served as ... Wayne Carman transitioned to chief of the Division of Plastic Surgery at what is ... chief and began a second three-year term in January of 2016. , The original ...
(Date:2/5/2016)... ... February 05, 2016 , ... Regular gym users know ... having to wait longer to access the treadmills. It’s a predictable trend. After the ... lose weight and get in shape by joining gyms, starting new walking or running ...
(Date:2/5/2016)... Georgia (PRWEB) , ... February 05, 2016 , ... Dr. ... to announce their 2nd Annual No Cost Dental Day to individuals in need. The ... The purpose of this No Cost Dental Day is to provide dental care to ...
(Date:2/5/2016)... ... February 05, 2016 , ... Health and wellness is a topic that should ... event they are experiencing an illness. Migraines are a severe form of a headache ... migraines would not wish the pain on their worst enemy, the feeling can last ...
Breaking Medicine News(10 mins):