MEMPHIS, Tenn.--(BUSINESS WIRE)--Apr. 15, 2013--
GTx, Inc. (Nasdaq: GTXI) today announced that a per protocol safety
review of unblinded safety data on Friday April 12, 2013, by an
independent Data Safety Monitoring Board (DSMB), resulted in a
determination that GTx continue as planned its two pivotal Phase III
clinical trials of enobosarm (GTx-024) for the prevention and treatment
of muscle wasting in patients with advanced non-small cell lung cancer.
The DSMB has met regularly every six months to review safety data from
the two pivotal Phase III clinical trials and will not meet again until
the data is locked and unblinded for a final assessment of safety data
from the two studies.
"We are pleased that the DSMB has recommended that GTx continue as
planned with our clinical studies of enobosarm under the existing
protocols,” said Mitchell S. Steiner, MD, Chief Executive Officer of
GTx. “The extensive safety database GTx is compiling from the numerous
clinical studies of enobosarm will be a critical component of GTx’s
application for marketing approval, which we hope to submit following
receipt of topline data from our Phase III clinical trials in the 3rd
quarter of 2013."
GTx has completed enrollment of approximately 650 subjects with advanced
non-small cell lung cancer in two pivotal Phase III clinical trials,
POWER 1 and POWER 2. These international Phase III studies are being
conducted in clinical sites in the United States, Europe, Russia and
South America. In each of the placebo-controlled, double-blind clinical
trials, approximately 325 patients with Stage III or IV non-small cell
lung cancer have been randomized to oral daily doses of placebo or
enobosarm 3 mg at the time they begin first line standard chemotherapy.
The studies are evaluating as co-primary endpoints at three months of
treatment the response rates of enobosarm versus placebo on maintaining
or improving total lean body mass (muscle) assessed by dual x-ray
absorptiometry and improving physical function assessed by the Stair
Climb Test. Durability of the drug effect is being evaluated as a
secondary endpoint at five months of treatment. Topline data from the
studies should be released during the third quarter of 2013.
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 trials 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 annual
report on Form 10-K filed with the Securities and Exchange Commission on
March 5, 2013 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.
Source: GTx, Inc.
Marc Hanover, 901-523-9700
President and Chief