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GTx Announces Late Breaker Presentation on Results from the two Phase 3 POWER Trials of enobosarm, a selective androgen receptor



  GTx Announces Late Breaker Presentation on Results from the two Phase 3
  POWER Trials of enobosarm, a selective androgen receptor modulator (SARM),
  for the prevention and treatment of muscle wasting in NSCLC patients during
  2013 European Cancer Congress

ECC 2013

Business Wire

MEMPHIS, Tenn. -- September 24, 2013

GTx, Inc. (Nasdaq: GTXI) announced today that top line results from the two
Phase 3 trials (POWER1 and POWER2) on the effects of enobosarm for the
prevention and treatment of muscle wasting in non-small cell lung cancer
patients will be presented on September 28, 2013, at the European Cancer
Congress 2013 (September 27-October 1, 2013) in Amsterdam.

Jeffrey Crawford, M.D., Chief, Division of Medical Oncology at Duke University
School of Medicine, and principal investigator for the POWER1 and POWER2
clinical studies will present the results on September 28^th, 2013 at 1:39PM
(Elicium 2) during the Proffered Papers Session: Lung Cancer - Localised and
Metastatic (11:00-14:00).

The abstract number is LBA 21: Results from two Phase 3 randomized trials of
enobosarm, selective androgen receptor modulator (SARM), for the prevention
and treatment of muscle wasting in NSCLC.

About The POWER Trials

A 3 mg dose of enobosarm was studied in two Phase 3 clinical trials to prevent
and treat muscle wasting in patients with NSCLC. In each of these placebo
controlled, double blind clinical trials, approximately 325 patients with
stage III or IV NSCLC were randomized to oral daily doses of placebo or
enobosarm 3 mg at the time they began first-line standard platinum doublet
chemotherapy. The POWER trials were designed to assess the response rates of
enobosarm versus placebo for the co-primary endpoints at 3 months of treatment
on maintenance or improvement of total lean body mass (muscle) assessed by
Dual-energy X-ray Absorptiometry (DXA) and improvement in physical function
measured by the stair climb test (power). Durability of enobosarm treatment
was assessed at five months. Secondary endpoints included an assessment of
whether enobosarm-treated patients had an improved quality of life and reduced
healthcare resource utilization compared to placebo. Overall survival is being
assessed as an additional safety endpoint. GTx announced earlier this year
that the FDA has designated enobosarm for the prevention and treatment of
muscle wasting in patients with NSCLC as a Fast Track development program.

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 July 22, 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.

Contact:

GTx, Inc.
Marc Hanover, 901-523-9700
President
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