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                                                                    Exhibit 99.1

Contact:
McDavid Stilwell
Manager, Corporate Communications and Financial Analysis
GTx, Inc.
(901) 523-9700


          GTx Receives FDA Response on Special Protocol Assessment for
                   ACAPODENE for Prevention of Prostate Cancer

Memphis, Tenn, Sept. 14, 2005 - GTx, Inc. (Nasdaq: GTXI), the Men's Health
Biotech Company, today announced it has received a response letter from the
Division of Oncology Drug Products of the United States Food and Drug
Administration related to GTx's Special Protocol Assessment (SPA) on the design
of its pivotal Phase III clinical trial of ACAPODENE(R) for the prevention of
prostate cancer in high risk men. GTx agrees with and will implement the FDA's
recommendations under the SPA, which GTx expects will be sufficient to support
the submission of the effectiveness portion of a New Drug Application.

The pivotal Phase III trial is a randomized, double-blind, placebo-controlled
study of 1,260 patients who receive daily either an oral 20 mg dose of ACAPODENE
or placebo. Trial participants have high grade prostatic intraepithelial
neoplasia (PIN), a premalignant lesion of the prostate. The primary endpoint of
the trial is a reduction in prostate cancer incidence as determined by prostate
biopsy. GTx will evaluate efficacy endpoints at 36 months, with an interim
analysis at 24 months. If a sufficient reduction in prostate cancer at 24 months
is achieved, GTx could potentially file a New Drug Application, provided that
GTx is also able to submit as part of the filing safety data for 36 months for a
majority of patients and other safety data, as requested by the FDA. The
statistical assumptions for the design of this Phase III trial are based on the
positive results of the Phase IIb high grade PIN trial in 514 patients completed
in June 2004.

Enrollment of the trial began in early 2005 and is on schedule to be completed
in the first quarter of 2006.

About GTx

GTx is a biopharmaceutical company dedicated to the discovery, development and
commercialization of therapeutics for cancer and serious conditions related to
men's health. GTx's lead drug discovery and development programs are focused on
small molecules that selectively modulate the effects of estrogens and
androgens, two essential classes of hormones. GTx, headquartered in Memphis,
Tenn., currently has four clinical programs. GTx is developing ACAPODENE(R)
(toremifene citrate), a selective estrogen receptor modulator, or SERM, in two
separate clinical programs in men: (1) a pivotal Phase III clinical trial for
the treatment of serious side effects of androgen deprivation therapy for
advanced prostate cancer and (2) a pivotal Phase III clinical trial for the
prevention of prostate cancer in high risk men with precancerous prostate
lesions. In its third clinical program, GTx is developing ostarine for the
treatment of muscle wasting associated with acute conditions such as burns and
chronic conditions such as andropause. GTx expects to begin Phase II clinical
trials of ostarine for muscle wasting associated with burns in the fourth
quarter of 2005 and for andropause during the first half of 2006. In its fourth
clinical program, GTx and its collaborator, Ortho Biotech Products, L.P., a
subsidiary of Johnson & Johnson, are developing andarine, another one of





GTx's SARMs, for the treatment of cancer cachexia. GTx is working with Ortho
Biotech to plan a Phase II clinical trial of andarine.

Forward-Looking Information is Subject to Risk and Uncertainty

This press release contains forward-looking statements, including, without
limitation, statements related to the regulatory approval process for ACAPODENE,
the timing of the filing of an New Drug Application for ACAPODENE, GTx's planned
clinical trials of ACAPODENE, the date by which enrollment in GTx's Phase III
trial of ACAPODENE for the prevention of prostate cancer in high risk men is
expected to be completed, and its other research and development programs. These
forward-looking statements are 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 and
other important factors, which include, without limitation, risks that GTx will
not be able to commercialize its product candidates if clinical trials do not
demonstrate safety and efficacy in humans; risks related to GTx's dependence on
third parties; and if the Company is not able to obtain required regulatory
approvals, the Company will not be able to commercialize its product candidates.
You should not place undue reliance on these forward-looking statements, which
apply only as of the date of this press release. The annual report filed on Form
10-K/A with the U.S. Securities and Exchange Commission (the "SEC") on August 3,
2005 contains under the heading "Additional Factors That Might Affect Future
Results," a more comprehensive description of these and other important factors
and 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.