�QuatRx Pharmaceuticals, a
privately-held biopharmaceutical company focused on development and
commercialization of compounds to treat endocrine, metabolic and
cardiovascular disorders, announced that it has initiated a second
Phase 3 clinical trial of Ophena(TM) (ospemifene tablets), the company's
estrogen-free oral therapy in development for the treatment of vaginal
symptoms associated with menopause.
The study is the secondment pivotal Phase 3 clinical trial for Ophena(TM),
a new selective estrogen receptor modulator (SERM) for the treatment of
postmenopausal vaginal syndrome (PVS), a common condition in postmenopausal
women. PVS, also known as vaginal atrophy, is characterized by progressive
long-term vaginal symptoms such as dryness, irritation and sexual pain
(dyspareunia). The first Phase 3 test for Ophena(TM) met all the
co-primary endpoints at a 60 mg dose, with statistically significant
improvements in vaginal dryness and dyspareunia, as well as statistically
significant improvement in the proportion of parabasal and superficial
cells in the epithelial tissue of vaginal walls and a decline in vaginal pH
levels.
The randomised, double-blind study will seek to inscribe 750
postmenopausal women at more than 100 trial centers throughout the United
States. Women participating in the study will be treated with either a 60
mg once daily oral dose of Ophena(TM) or placebo over the 12-week discussion
period. All women will also be supplied with a non-hormonal vaginal
lube to be applied as needed during the discussion period.
The co-primary endpoints of the study ar the change from baseline to
week 12 in the percentage of parabasal cells in the vaginal maturation
forefinger, the part of trivial cells in the vaginal maturation index,
vaginal pH, and improvements in the most pesky moderate to severe
vulvovaginal atrophy symptoms of vaginal dryness and dyspareunia.
"We were very pleased with the results of the first Phase 3 run for
Ophena(TM) and believe this adjacent pivotal study will present another
important development milestone for QuatRx," said Robert L. Zerbe, M.D.,
headman executive officeholder and president of QuatRx. "For the large population
of postmenopausal women affected by progressive and vexatious vaginal
symptoms, and specially those implicated about the health risks associated
with long-term estrogen-based therapy, we believe Ophena(TM) has the
potential to be an important new treatment option."
About Postmenopausal Vaginal Syndrome
Postmenopausal vaginal syndrome (PVS) is a chronic and progressive
condition characterized by symptoms including vaginal dryness, sexual pain
(dyspareunia) and irritation. Declining oestrogen levels during menopause
can cause tissues of the vaginal lining to grow thinner and to misplace
elasticity, a condition known as withering. Dryness and irritation associated
with reductions in vaginal secretions much cause hurting or hemorrhage during
sexual intercourse. It is estimated that 45-75 percent of post-menopausal
women experience chronic symptoms of PVS. Current prescription treatments
approved for this condition all comprise estrogen, administered either
by word of mouth or locally in the vagina. SERMs that ar currently approved and
marketed in the United States have non been shown to get beneficial
personal effects on vaginal tissue and none ar approved for use in treating
symptoms of PVS.
About QuatRx
QuatRx Pharmaceuticals is focused on the discovery, licensing,
development and commercialization of compounds in the endocrine, metabolic
and cardiovascular therapeutic areas. In improver to Ophena(TM), QuatRx has
three other product candidates in alive clinical growth and an
advanced presymptomatic program. 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. Sobetirome, a novel, selective
thyroidal receptor beta agonist, is in Phase 1 as a potential treatment for
dyslipidemia. Becocalcidiol, a novel Vitamin D analogue, is in Phase 2
clinical trials for the treatment of psoriasis through QuatRx's partner,
Galderma. QuatRx's preclinical program is designed to address sex steroid
pendant diseases through inhibition of 17beta-HSD enzymes. In Europe,
QuatRx operates through its Finnish subsidiary, Hormos Medical Ltd, situated
in Turku, Finland. For press releases and other Company entropy, please
chatter http://www.quatrx.com.
QuatRx Pharmaceuticals
http://www.quatrx.com
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