-- Data presented at the International
Continence Society Annual Meeting today demonstrated:
* Clinically significant reductions in
incontinence episodes per day in all patients completing 12 week
treatment
* Reductions in incontinence episodes were
sustained for up to 7 months following completion of enobosarm
treatment
-- Placebo-controlled Phase 2 clinical trial
designed to further evaluate enobosarm in postmenopausal women with
SUI initiated in August 2017 --
GTx, Inc. (Nasdaq: GTXI) today announced top-line clinical trial
results demonstrating that a daily dose of enobosarm 3 mg (GTx-024)
substantially improved stress urinary incontinence (SUI) in women,
as well as related quality of life measurements. In this open-label
clinical trial, all 17 patients completing 12 weeks of treatment
saw a clinically significant reduction (50 percent or greater) in
stress leaks per day, compared to baseline. Mean stress leaks
decreased by 83 percent from baseline over 12 weeks, and the
reductions in daily stress leaks following completion of treatment
have been sustained as patients are being followed for up to 7
months post-treatment to assess the durability of treatment effect.
No patient has relapsed to her baseline levels. These results were
presented at the International Continence Society (ICS) Annual
Meeting currently being held in Florence, Italy from September
12-15, 2017.
“All 17 patients completing treatment have shown a significant
reduction in the number of leaks per day recorded at their
baseline, and the improvements in symptoms were sustained well
beyond ceasing enobosarm treatment at 12 weeks,” said Kenneth M.
Peters, M.D., Chairman of Urology, Oakland University William
Beaumont School of Medicine, and the principal investigator in the
trial. “The results in this proof-of-concept study are promising,
and we are excited to be participating in a larger,
placebo-controlled Phase 2 study.”
The podium presentation entitled “Kegels In A Bottle”:
Preliminary Results Of A Selective Androgen Receptor Modulator
(GTx-024) For The Treatment Of SUI In Post-Menopausal Women,
summarized clinical data from the first 17 patients completing 12
weeks of enobosarm treatment, including the duration of response
for up to 7 months following completion of enobosarm treatment. In
this trial, a total of 19 post-menopausal women were enrolled by
three clinical sites to receive enobosarm treatment. In addition to
the 17 patients who completed treatment, another will complete
treatment in approximately 8 weeks and one patient previously
withdrew consent shortly after her initial visit. Data highlights
were as follows:
Each of the women treated with enobosarm showed a clinically
significant reduction in incontinence episodes per day:
- Mean stress leaks decreased by 83%
percent from baseline over 12 weeks
- Stress leaks decreased from a mean of
5.08 leaks/day at baseline, to 0.88 leaks/day at Week 12
- All 17 patients achieved the primary
endpoint of reductions in leaks per day, compared to baseline, of
at least 50% at Week 12
Reductions in incontinence episodes were sustained well beyond
the 12 week treatment period:
- Patients are being followed for up to 7
months post-treatment to assess duration of the drug’s effect, and
to date no patient, including 6 patients who have reached 7 months,
has returned to her baseline levels of SUI episodes
Women reported improved quality of life measurements in each of
the five instruments collected in the study, including the Patient
Global Impression of Improvement (PGI-I) and Female Sexual Function
Index (FSFI):
- At Week 12, 16 of 17 patients showed
improved PGI-I scores and median FSFI scores improved from a
baseline score of 15.90 to 28.05 at Week 12
There were no serious adverse events reported and reported
adverse events were minimal and included headaches, nausea,
fatigue, hot flashes, insomnia, muscle weakness and acne. Mild
transient elevations in liver enzymes were observed, as well as
reductions in total cholesterol, LDL, HDL and triglycerides. The
presentation can be found on the Company’s website. The abstract is
available on the International Continence
Society’s website.
Based on the results from its enobosarm Phase 2 proof-of-concept
study, the Company has initiated a randomized, placebo-controlled
Phase 2 clinical trial to evaluate the change in frequency of daily
stress urinary incontinence episodes following 12 weeks of
treatment. The trial will evaluate the safety and efficacy of
enobosarm (1 mg and 3 mg) compared with placebo in postmenopausal
women with SUI. Enobosarm has previously been evaluated in clinical
trials enrolling in excess of 1,700 patients, in which
approximately 1,200 individuals received doses ranging from 0.1 mg
to 100 mg, and has been observed to be generally safe and well
tolerated.
“Since stress incontinence occurs when muscles that control
one’s ability to hold urine get weak or do not work, it stands to
reason that increasing pelvic floor muscle mass should reduce
involuntary or unintentional leakage of urine,” said Dr. William J.
Evans, Adjunct Professor in the geriatrics program at the Duke
University Medical Center. “The muscles of the pelvic floor are
enriched with androgen receptors and are responsive to the body’s
hormonal status which is why we hypothesize that a selective
androgen receptor modulator, like enobosarm, could have a
beneficial effect on SUI.”
About the Phase 2 Proof-of-Concept Clinical Trial
The single-arm, open-label Phase 2 clinical trial is evaluating
enobosarm in postmenopausal women with SUI, and is the first
clinical trial to evaluate an orally administered selective
androgen receptor modulator (SARM) for SUI. More information about
the clinical trial can be found here.
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 35
percent of adult women. 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 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, in 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 the
ongoing proof-of-concept Phase 2 clinical trial of enobosarm 3 mg
for the treatment of postmenopausal women with SUI.
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
muscle-related diseases 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 trials of, and the
therapeutic potential of, enobosarm (GTx-024) to treat 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 clinical trials being conducted by GTx may not be completed on
schedule, or at all, or may otherwise be suspended or terminated;
(ii) that the development of enobosarm to treat SUI is at an early
stage, is subject to the substantial risk of failure inherent in
the development of early-stage product candidates, and will require
significant additional financial resources in order for such
development to continue; (iii) that any additional clinical
development of enobosarm to treat SUI is contingent on GTx entering
into new collaborative arrangements with third parties for such
development or otherwise obtaining sufficient additional capital to
permit such development, which it may be unable to do; and (iv)
that GTx may not be able to obtain required regulatory approvals to
commercialize enobosarm in a timely manner or at all. 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 June 30, 2017, filed August 14, 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170913005298/en/
Investors:GTx, Inc.Lauren Crosby,
901-271-8622lcrosby@gtxinc.comorMedia:Red House ConsultingDenise
Powell, 510-703-9491denise@redhousecomms.com
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