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QuatRx Pharmaceuticals Announces Positive Phase 3 Results For Study Of Ophena(TM) (ospemifene) To Treat Postmenopausal Vaginal Syndrome
QuatRx Pharmaceuticals Company
announced positive results from a pivotal Phase 3 study of Ophena(TM)
(ospemifene) to treat postmenopausal women with vulvovaginal atrophy, a
common condition associated with menopause. Top line data show that the
multi-center, double-blind, placebo-controlled study successfully met all
of its co-primary endpoints. The study was conducted in 80 U.S. centers and
involved more than 800 women. Full results of the study are being submitted
to an upcoming scientific meeting for release later in 2008.
Ophena(TM) is a novel selective estrogen receptor modulator (SERM) that
is being studied as a treatment for women with postmenopausal vaginal
syndrome (PVS), also known as vaginal atrophy. PVS is a common condition in
postmenopausal women characterized by symptoms such as vaginal dryness,
irritation and pain associated with sexual intercourse. The only currently
FDA approved products for this condition all contain the hormone estrogen.
However, many women and their physicians avoid using estrogen-containing
products due to concerns about the risks of such therapy identified in the
Women's Health Initiative (WHI) and other studies.
"These results are very exciting and we believe demonstrate that
Ophena(TM) has the potential to bring clear clinical benefit to women
affected by PVS, many of whom have had only estrogen therapy as a treatment
option for their condition to date," said Robert L. Zerbe, M.D., chief
executive officer and president of QuatRx. "We believe Ophena(TM) could
provide the first non- estrogen prescription treatment alternative for this
condition. QuatRx is well positioned to continue with our plans to advance
this exciting product to commercialization, pending regulatory review and
approval."
This pivotal Phase 3 study was designed to evaluate the efficacy of
Ophena(TM) versus placebo over a 12-week treatment period in women with
moderate to severe symptoms of vulvar and vaginal atrophy associated with
menopause. A total of 826 women were enrolled in the study.
The primary endpoints for the Phase 3 Ophena(TM) clinical trial were
defined as the change from baseline to week 12 in the percentage of
parabasal cells in the vaginal maturation index, the percentage of
superficial cells in the vaginal maturation index, vaginal pH, and the most
bothersome moderate to severe vulvovaginal atrophy symptom, consistent with
the appropriate FDA guidance. Top-line data indicate that the study
achieved a statistically significant result in each of these co-primary
endpoints and that Ophena(TM) was well tolerated.
The study investigated two doses of Ophena(TM) versus placebo,
administered once daily, with patients randomized (1:1:1) into a
double-blind 12-week treatment period with a four-week follow-up or the
opportunity to continue in a long-term safety extension study. All subjects
were supplied with a non-hormonal vaginal lubricant to be applied as needed
during the 12- week treatment period.
Rochelle Hanley, M.D., chief medical officer of QuatRx Pharmaceuticals,
added, "Based on this study, we believe Ophena(TM) is the first drug to
demonstrate efficacy in this population over and above the use of topical
lubricants. These are important new data that underscore the clinical
benefit Ophena(TM) could provide for this common chronic condition."
The full data set from the study is currently being analyzed and will
be submitted for presentation at an upcoming scientific meeting and for
publication in an appropriate peer-reviewed setting.
About Postmenopausal Vaginal Syndrome
Postmenopausal vaginal syndrome (PVS) is a chronic condition
characterized by symptoms including vaginal dryness, sexual pain
(dyspareunia), and irritation. Declining estrogen levels during menopause
can cause tissues of the vaginal lining to grow thinner and to lose
elasticity, a condition known as atrophy. Dryness and irritation associated
with reductions 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. It is
estimated that up to 40% of post-menopausal women have symptoms of PVS.
Current prescription treatments approved for this condition all contain
estrogen, administered either orally or locally in the vagina. SERMs that
are currently approved and marketed in the United States have not been
shown to have beneficial effects on vaginal tissue and none are approved
for use in treating this condition.
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. Asord(TM) (becocalcidiol), a
novel Vitamin D analogue, is in Phase 2 clinical trials for the treatment
of psoriasis through QuatRx's partner, CollaGenex Pharmaceuticals, Inc.
QuatRx's two preclinical small molecule programs are designed to address
common endocrine disorders in women and men. In Europe, QuatRx operates
through its Finnish subsidiary, Hormos Medical Ltd, located in Turku,
Finland. For press releases and other Company information, please visit
http://www.quatrx.com.
QuatRx Pharmaceuticals Company
http://www.quatrx.com
QuatRx Pharmaceuticals Announces pozitive Faza 3 Rezultate pentru studierea Ophena (TM) (ospemifene) pentru a trata menopauzã vaginale Sindromul - QuatRx Pharmaceuticals Announces Positive Phase 3 Results For Study Of Ophena(TM) (ospemifene) To Treat Postmenopausal Vaginal Syndrome - articole medicale engleza - startsanatate