�QuatRx Pharmaceuticals, a
privately-held biopharmaceutical company focused on development and
commercialization of compounds to treat internal secretion, 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 exploitation for the treatment of vaginal
symptoms associated with menopause.
The study is the instant pivotal Phase 3 clinical trial for Ophena(TM),
a new selective estrogen sensory receptor modulator (SERM) for the treatment of
postmenopausal vaginal syndrome (PVS), a common condition in postmenopausal
women. PVS, too known as vaginal atrophy, is characterized by progressive
long-term vaginal symptoms such as waterlessness, irritation and sexual pain
(dyspareunia). The first Phase 3 tribulation 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
meaning 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 search to recruit 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 everyday oral lucy in the sky with diamonds of Ophena(TM) or placebo over the 12-week intervention
period. All women testament also be supplied with a non-hormonal vaginal
lubricating substance to be applied as needed during the treatment period.
The co-primary endpoints of the study ar the change from baseline to
week 12 in the per centum of parabasal cells in the vaginal maturation
index, the percentage of superficial cells in the vaginal maturation index,
vaginal pH, and improvements in the most irritating moderate to severe
vulvovaginal atrophy symptoms of vaginal dryness and dyspareunia.
"We were identical pleased with the results of the first Phase 3 trial for
Ophena(TM) and conceive this following pivotal study will typify another
important development milestone for QuatRx," said Robert L. Zerbe, M.D.,
head executive officer and president of QuatRx. "For the large population
of postmenopausal women affected by progressive and pestiferous 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 inveterate and progressive
condition characterized by symptoms including vaginal dryness, sexual pain
(dyspareunia) and botheration. Declining oestrogen levels during menopause
can buoy cause tissues of the vaginal facing to mature thinner and to miss
elasticity, a condition known as withering. Dryness and irritation associated
with reductions in vaginal secretions oft cause pain sensation or hemorrhage during
sexual intercourse. It is estimated that 45-75 percent of post-menopausal
women experience inveterate symptoms of PVS. Current prescription treatments
approved for this circumstance all bear estrogen, administered either
orally or locally in the vagina. SERMs that ar currently approved and
marketed in the United States have non been shown to have beneficial
effects on vaginal tissue and none are approved for use in treating
symptoms of PVS.
About QuatRx
QuatRx Pharmaceuticals is focused on the discovery, licensing,
evolution and commercialization of compounds in the endocrine, metabolous
and cardiovascular therapeutic areas. In addition to Ophena(TM), QuatRx has
three other product candidates in active clinical development and an
advanced presymptomatic program. Fispemifene is a new selective estrogen
sensory receptor antagonist that is in Phase 2 studies as an oral treatment for the
symptoms of secondary hypogonadism in men. Sobetirome, a novel, selective
thyroid receptor beta agonist, is in Phase 1 as a potency 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 presymptomatic program is designed to address sex steroid
dependent diseases through inhibition of 17beta-HSD enzymes. In Europe,
QuatRx operates through its Finnish subsidiary company, Hormos Medical Ltd, placed
in Turku, Finland. For press releases and other Company info, please
chaffer http://www.quatrx.com.
QuatRx Pharmaceuticals
http://www.quatrx.com
More info
