MEMPHIS, Tenn.--(BUSINESS WIRE)--Jan. 8, 2013--
GTx, Inc. (Nasdaq: GTXI) today announced that the U.S. Food and Drug
Administration (FDA) has designated enobosarm (GTx-024) for the
prevention and treatment of muscle wasting in patients with non-small
cell lung cancer as a Fast Track development program. Fast Track status
is a process designed by FDA to facilitate the development and expedite
the review of new drug candidates that are intended to treat serious
diseases and have the potential to fill an unmet medical need. With a
Fast Track designation, there is an increased possibility for a priority
review of a new drug application (NDA) filed for the drug candidate and
more opportunity for more frequent interactions with the FDA both prior
to and following the filing of a NDA.
GTx is assessing the ability of enobosarm to prevent and treat muscle
wasting in non-small cell lung cancer patients in two pivotal Phase III
clinical trials, POWER 1 and POWER 2. In each of the placebo-controlled,
double-blind clinical trials, approximately 300 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 began first line
standard platinum doublet chemotherapy. The studies are evaluating as
co-primary endpoints at three months of treatment the responder rates of
enobosarm versus placebo on maintaining or improving total lean body
mass (muscle) assessed by dual x-ray absorptiometry and improving
physical function measured by the Stair Climb Test. Durability of the
drug effect is being evaluated as a secondary endpoint at five months of
treatment.
“We are very pleased that FDA has recognized enobosarm as a drug
candidate with the potential to address the serious and unmet medical
need of preventing and treating muscle wasting in non-small cell lung
cancer patients,” said Mitchell Steiner, MD, CEO of GTx. “With
approximately 650 patients fully enrolled in our two definitive Phase
III clinical studies of enobosarm, we expect to receive top line data
from these studies this summer. Assuming the data supports our ability
to do so, we will move quickly to meet with FDA to discuss the filing of
a new drug application for enobosarm.”
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 quarterly
report on Form 10-Q filed with the Securities and Exchange Commission on
November 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.
Source: GTx, Inc.
GTx, Inc.
Marc Hanover, President and Chief Operating Officer,
901-523-9700
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