GTx, Inc. (Nasdaq: GTXI) announced that additional efficacy and safety
analyses from the Phase III clinical trial evaluating toremifene 80 mg
for the treatment of multiple side effects of androgen deprivation
therapy (ADT) in men with advanced prostate cancer will be presented
September 16th in an oral session at the 2008 Annual Meeting of the
American Society for Bone and Mineral Research being held in Montreal,
Canada.
The presentation will highlight bone turnover marker data as well as an
additional supportive safety analysis regarding the effect of toremifene
80 mg in men with advanced prostate cancer on ADT.
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Abstract:
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"C-telopeptide and Bone Alkaline Phosphatase Predict Morphometric
Vertebral Fracture Risk in a Pivotal Phase III trial of Toremifene
in Men on ADT"
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Session Number:
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47
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Session Title:
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Osteoporosis Treatment (clinical) IV: John H. Carstens Memorial
Session
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Presentation Start/End Time:
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Tuesday, Sept. 16, 2008, 11:15 a.m. - 11:30 a.m. ET
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Location:
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Palais des congres de Montreal, Room 517 ABC
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About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical
company dedicated to the discovery, development, and commercialization
of small molecules that selectively target hormone pathways to treat
cancer, osteoporosis and bone loss, muscle wasting and other serious
medical conditions. GTx is developing toremifene citrate, a selective
estrogen receptor modulator, or SERM, in two separate clinical programs
in men: first, a completed pivotal Phase III clinical trial evaluating
toremifene 80 mg for the treatment of serious side effects of androgen
deprivation therapy for advanced prostate cancer, and second, an ongoing
pivotal Phase III clinical trial evaluating toremifene 20 mg for the
prevention of prostate cancer in high risk men with high grade prostatic
intraepithelial neoplasia, or PIN. In 2006, GTx and Ipsen Group entered
into a development and collaboration agreement for toremifene citrate in
all indications except breast cancer for Europe and the Commonwealth of
Independent States (CIS). GTx will file for marketing approval and, if
approved, plans to commercialize toremifene 80 mg in the United States.
In December 2007, GTx and Merck & Co., Inc. formed a collaboration to
discover and develop selective androgen receptor modulators (SARMs), a
new class of drugs with the potential to treat sarcopenia, which is the
loss of skeletal muscle mass resulting in reduced physical strength and
ability to perform activities of daily living, cancer cachexia (muscle
wasting), as well as other musculoskeletal conditions. Merck and GTx are
conducting several Phase I and Phase II clinical trials evaluating
multiple SARM product candidates including Ostarine™
(also designated as MK-2866) for sarcopenia. Ostarine is also in a Phase
II clinical trial for cancer cachexia which will be completed in 2008.
Merck and GTx are evaluating additional muscle loss indications for
potential SARM clinical development. GTx also is developing its
preclinical compounds, GTx-758, an oral LH inhibitor for advanced
prostate cancer, and GTx-878, an estrogen receptor beta agonist for the
treatment of benign prostatic hyperplasia and chronic prostatitis.
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. 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 that (i) GTx and its
collaboration partners will not be able to commercialize their product
candidates if clinical trials do not demonstrate safety and efficacy in
humans; (ii) GTx may not able to obtain required regulatory approvals to
commercialize product candidates; (iii) clinical trials being conducted
by GTx and its collaboration partners may not be completed on schedule,
or at all, or may otherwise be suspended or terminated; and (iv) 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 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 August 5, 2008 contain 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.
GTx, Inc.
McDavid Stilwell, 901-523-9700
Director, Corporate
Communications & Financial Analysis