GTx's Phase III Clinical Studies of Enobosarm (GTx-024) to Continue as Planned Following Planned Safety Review
April 15 2013 - 7:30AM
Business Wire
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.
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 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.
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