GTx, Inc. (NASDAQ: GTXI) announced today there will be two scientific
poster presentations on the effects of enobosarm, a selective androgen
receptor modulator (SARM), on improving physical function and quality of
life in middle aged and elderly cancer patients. The posters will be
displayed on October 26th and 27th, 2012, at the
12th Meeting of the International Society of Geriatric Oncology to be
held at the Manchester Central Convention Centre in Manchester, United
Kingdom. Ryan P. Taylor, PhD, GTx’s Associate Director of Medical
Affairs, will present data from the company’s Phase IIb clinical study
of enobosarm, providing evidence that enobosarm may play an important
role in the management of cancer patients with muscle wasting by
improving physical function and quality of life, regardless of baseline
weight loss or age.
The first poster presentation will present data exploring patient
response to treatment by grouping subjects according to their baseline
weight loss (less or greater than 5% in the 6 month period prior to
randomization), and the age of the patient (above and below the median
age of 66 years). Of the 159 subjects randomized into the study, 103 had
physical function (by stair climb test) assessed at both baseline and
following 16 weeks of treatment and 24% of these subjects had lost less
than 5% of weight. Significant improvement in physical function was
observed in enobosarm treated subjects, while placebo subjects failed to
improve, regardless of baseline weight loss or age.
The second poster presentation will present data indicating that
patients, who responded to treatment during the enobosarm clinical study
(>10% improvement in stair climb power), significantly increased three
separate measures of quality of life, regardless of age. Quality of life
questionnaires from 95 of the 159 subjects randomized into the study
were analyzed to determine if there was an association between
improvement in stair climb power (the physical function test assessed
during the clinical study) and quality of life. Generally, a 5% increase
in physical function from baseline is regarded as a minimal clinically
meaningful change in physical function, while a 10% increase in physical
function from baseline is thought to be a substantial clinically
meaningful change. Subjects who showed improvements in stair climb power
also were found to have improvements in quality of life, and subjects
with the greatest stair climb improvement also had the greatest measured
improvements in quality of life.
Enobosarm is a SARM which binds to the androgen receptor and is designed
to deliver the beneficial effects of androgens while minimizing unwanted
clinical side effects. GTx conducted its Phase IIb clinical study of
enobosarm in 159 cancer patients (average age of 66 years) in 35 sites
in the United States and Argentina. Participants were randomized to
receive placebo, 1 mg or 3 mg oral tablet of enobosarm once daily for 16
weeks. Average reported weight loss prior to entry among all subjects
was 8.8%, and subjects were allowed to have standard chemotherapy during
the trial. The drop-out rate during the trial was 33%. The study met its
primary endpoint of absolute change in total lean body mass (muscle)
compared to placebo after 16 weeks of treatment.
GTx is conducting two pivotal Phase III clinical trials (POWER 1 and
POWER 2) in the United States, Europe and South America, evaluating a
once daily 3 mg dose of enobosarm for the prevention and treatment of
muscle wasting in patients with non-small cell lung cancer. More
information about these two clinical studies can be found at www.gtxclinicaltrials.com.
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, cancer supportive care,
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 clinical trial for enobosarm (also known as Ostarine® or
GTx-024). 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 GTx will not be able to commercialize its
product candidates if clinical trials do not demonstrate safety and
efficacy in humans; (ii) that GTx may not be able to obtain required
regulatory approvals to commercialize its product candidates in a timely
manner or at all; (iii) that clinical trials being conducted by GTx may
not be completed on schedule, or at all, or may otherwise be suspended
or terminated; or (iv) that GTx could utilize its available cash
resources sooner than it currently expects and may be unable to raise
capital when needed, which would force GTx to delay, reduce or eliminate
its product candidate development programs or commercialization efforts.
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 filed with the Securities and Exchange Commission on
August 8, 2012 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.
