GTx Announces Positive Preliminary Results from Ongoing Phase 2 Proof-of-Concept Clinical Trial in Women with Stress Urinary ...
June 12 2017 - 7:00AM
Business Wire
-- Abstract on preliminary results accepted for
podium presentation at the International Continence Society Annual
Meeting --
-- Additional patient data to be included in
oral presentation on September 13, 2017, during a session on Female
Pelvic Floor Dysfunction --
GTx, Inc. (Nasdaq: GTXI) today announced release of preliminary
clinical data from its ongoing, open-label, Phase 2 clinical trial
of enobosarm 3 mg (GTx-024) in postmenopausal women with stress
urinary incontinence (SUI). An abstract entitled “Kegels In A
Bottle”: Preliminary Results Of A Selective Androgen Receptor
Modulator (GTx-024) For The Treatment Of SUI In Post-Menopausal
Women, summarizing clinical data from the first seven patients
completing 12 weeks of treatment with enobosarm, is now available
on the International Continence Society’s website. This
proof-of-concept clinical trial is the first of its kind to
evaluate an orally-administered selective androgen receptor
modulator (SARM) for SUI.
In this ongoing Phase 2 clinical trial, enobosarm 3 mg is being
given to post-menopausal women who have demonstrated SUI symptoms
for more than six months, with 3 to 15 reported SUI episodes per
day averaged over a three-day period, and a positive bladder stress
test. The primary endpoint is the number of SUI episodes per day on
the 3-day voiding diary at 12 weeks, compared to base line. The
clinical findings from the first seven patients enrolled in the
study following their completion of treatment, as outlined in the
abstract, are summarized below.
- Each of the women treated with
enobosarm showed a clinically significant reduction in incontinence
episodes per day:
- Mean stress leaks decreased by 80.9
percent from baseline over 12 weeks
- Stress leaks decreased from a mean of
5.7 leaks/day at baseline, to 1.1 leaks/day at Week 12
- All patients saw at least a 65 percent
reduction in number of stress leaks
- Reductions in incontinence episodes
were sustained well beyond the stopping of study drug at Week 12:
- Patients demonstrated continued
reduction in incontinence episodes for up to five months
- Women reported improved quality of life
in the Patient Global Impression of Improvement (PGI-I) and Female
Sexual Function Index (FSFI)
- At Week 12, all seven patients showed
improved PGI-I scores and 5 of 7 patients showed improvement in
FSFI
- Reported adverse events are minimal
with none above Grade I
“With approximately half the women in the United States
experiencing symptoms of SUI, there is a growing need for an
effective oral therapy to treat women with stress urinary
incontinence,” said Kenneth M. Peters, M.D., Professor and Chairman
of Urology, Oakland University William Beaumont School of Medicine.
“I am very encouraged by the consistency and strength of these
early results, and I look forward to presenting more detailed
clinical data from this ongoing clinical trial at the upcoming
International Continence Society (ICS) meeting.”
“What caught our attention was the fact that the first seven
patients dosed in this study saw impressive positive results. We
subsequently added two additional clinical trial sites, and we look
forward to presenting data from additional patients from this study
at the ICS meeting in September,” said Robert J. Wills, Ph.D.,
Executive Chairman of GTx. “We believe SUI represents a near-term
commercial opportunity in a potentially large population of women
whose treatment options are currently limited to non-pharmacologic
or invasive treatments.”
About the Phase 2 Proof-of-Concept Clinical Trial
Enrollment in the Phase 2 proof-of-concept clinical trial of 3
mg of enobosarm in women with SUI is ongoing. This is the first
clinical trial to evaluate a SARM for SUI. The
Company believes that developing an oral therapy to
potentially treat the large number of women who face a diminished
quality of life from stress urinary incontinence presents a unique
commercial opportunity, especially since current therapies may
sometimes involve invasive procedures. In the Phase 2 clinical
trial, 3 mg of GTx−024 is being given daily for 12 weeks to
post−menopausal women. The primary endpoint is the number of stress
incontinence episodes per day on the 3-day voiding diary. Secondary
endpoints include: pad weights, bladder stress test, and quality of
life instruments including the Female Sexual Function Index (FSFI)
and Patient Global Impression of improvement (PGI-I). More
information about the clinical trial can be found here.
About Enobosarm and SUI
Enobosarm, a selective androgen receptor modulator (SARM), has
been evaluated in 24 completed or ongoing clinical trials enrolling
over 1,700 subjects, of which approximately 1,200 subjects were
treated with enobosarm at doses ranging from 0.1 mg to 100 mg. At
all evaluated dose levels, enobosarm was observed to be generally
safe and well tolerated.
The rationale for evaluating enobosarm as a treatment for SUI is
supported by preclinical in vivo data demonstrating increases in
pelvic floor muscle mass following treatment with GTx’s SARM
compounds, including enobosarm, and data from the Company’s
on-going Phase 2 clinical trial continues to validate the use of
enobosarm as a potential treatment for SUI.
About Stress Urinary Incontinence
Stress urinary incontinence (SUI) refers to the unintentional
leakage of urine during activities that increase abdominal pressure
such as coughing, sneezing or physical exercise. SUI, the most
common type of incontinence suffered by women, affects up to 50
percent of adult women in the United States. There are a variety of
treatments that are used to treat SUI in women, such as behavioral
modification and pelvic floor physical therapy, especially as
initial treatment options. As the condition worsens however,
bulking agents and surgical procedures are often the most widely
used treatments.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a
biopharmaceutical company dedicated to the discovery, development
and commercialization of small molecules for the treatment of
cancer, including treatments for breast and prostate cancer, and
other serious medical conditions.
Forward-Looking Information is Subject to Risk and
Uncertainty
This press release contains forward-looking statements based
upon GTx's current expectations. Forward-looking statements involve
risks and uncertainties, and include, but are not limited to,
statements relating to GTx's ongoing clinical development of
enobosarm (GTx-024) for the treatment of stress urinary
incontinence (SUI). GTx's actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risks (i)
that the Phase 2 proof-of-concept study being conducted by GTx for
the treatment of SUI may not be completed on schedule; (ii) that
additional clinical development of enobosarm for the treatment of
SUI will be required beyond the ongoing study; and (iii) any future
development of enobosarm as a treatment for SUI is contingent on
obtaining sufficient additional capital to permit such development,
which it may be unable to do. In addition, GTx will continue to
need additional funding and may be unable to raise capital when
needed, which would force GTx to delay, reduce or eliminate its
product candidate development programs and potentially cease
operations. GTx’s actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties. You should
not place undue reliance on these forward-looking statements, which
apply only as of the date of this press release. GTx’s quarterly
report on Form 10-Q for the quarter ended March 31, 2017, contains
under the heading, “Risk Factors”, a more comprehensive description
of these and other risks to which GTx is subject. GTx expressly
disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained
herein to reflect any change in its expectations with regard
thereto or any change in events, conditions or circumstances on
which any such statements are based.
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version on businesswire.com: http://www.businesswire.com/news/home/20170612005351/en/
GTx, Inc.Investors:Lauren Crosby,
901-271-8622lcrosby@gtxinc.comorMedia:Red House ConsultingDenise
Powell, 510-703-9491denise@redhousecomms.com
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