Exhibit 99.1
Contact:
GTx, Inc. Burns McClellan, Inc.
Carney Duntsch Jonathan M. Nugent (investors)
Investor and Media Relations Kathy L. Jones-Nugent, Ph.D. (media)
901-523-9700 212-213-0006
cduntsch@gtxinc.com
GTx, INC. INITIATES PIVOTAL PHASE III CLINICAL TRIAL FOR
THE PREVENTION OF PROSTATE CANCER IN HIGH RISK MEN
Memphis, Tenn. -- January 26, 2005 - GTx, Inc. (Nasdaq: GTXI), a
biopharmaceutical company dedicated to the discovery, development and
commercialization of therapeutics for serious men's health conditions, today
announced that the company has initiated a pivotal Phase III clinical trial for
ACAPODENE(TM) for the prevention of prostate cancer in high risk men.
The company had an investigators meeting January 21-22, 2005, with approximately
100 U.S. clinical sites for its Phase III PIN trial. The pivotal Phase III trial
is a double blind, placebo controlled, multicenter study. Patients with high
grade prostatic intraepithelial neoplasia (PIN), the precancerous lesion in
prostate cancer, will be randomized into two treatment groups: 20 mg toremifene
or placebo. The primary endpoint of the clinical trial is the incidence of
prostate cancer.
GTx has received initial comments from the Food and Drug Administration (FDA) on
the preliminary review of the Special Protocol Assessment (SPA). As part of the
SPA process, GTx plans to address these comments and resubmit the revised SPA.
"We are excited about the initiation of GTx's pivotal Phase III trial for
ACAPODENE(TM) in men who are at high risk for prostate cancer," stated Mitchell
Steiner, M.D., Vice Chairman and CEO of GTx. "Providing a prevention option for
men who are at high risk for this premalignant disease is a top priority as
there are no treatment options currently available for these patients."
About ACAPODENE(TM)
ACAPODENE(TM) is a nonsteroidal SERM, a small molecule that binds and
selectively modulates the estrogen receptor. SERMs have been shown to block
estrogen receptors in the prostate. GTx has licensed the right to develop,
market and distribute toremifene citrate, the active ingredient of ACAPODENE(TM)
tablets, in all indications in the United States.
About High Grade PIN
It has been well established that patients with high grade PIN are at high risk
for developing prostate cancer. PIN is detected in approximately 9% of the
patients who undergo prostate biopsies. Prostate cancer is found in
approximately 30-70% of high grade PIN patients within one year of diagnosis,
and in 45-80% of high grade PIN patients within five years.
About GTx
GTx is a biopharmaceutical company dedicated to the discovery, development
and commercialization of therapeutics for serious men's health conditions. GTx's
drug discovery and development programs are focused on small molecules that
selectively modulate the effects of
estrogens and androgens. GTx currently has four clinical programs. In two of the
clinical programs, the company is developing ACAPODENE(TM), its most advanced
product candidate, through clinical trials for two separate indications: (1) a
pivotal Phase III clinical trial for the prevention of prostate cancer in high
risk men and (2) a pivotal Phase III clinical trial for the treatment of serious
side effects of androgen deprivation therapy for advanced prostate cancer. In
its third clinical program, GTx and its partner, Ortho Biotech Products, L.P., a
subsidiary of Johnson & Johnson, are developing andarine, a selective androgen
receptor modulator (SARM), which is expected to enter a Phase II clinical trial
in 2005. In its fourth clinical program, GTx is developing its own SARM,
ostarine, for andropause and other conditions related to aging, including
sarcopenia. In addition, GTx has a deep pipeline generated from its own
discovery program which includes specific preclinical product candidates
prostarine, a SARM, for benign prostatic hyperplasia (BPH), and andromustine, an
anticancer drug, for hormone refractory prostate cancer.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements, including, without
limitation, statements related to GTx's current and anticipated clinical trials
of ACAPODENE(TM) 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, which
include, without limitation, risks that GTx will not be able to commercialize
its product candidates if preclinical studies do not produce successful results
or clinical trials do not demonstrate safety and efficacy in humans; if third
parties do not manufacture the Company's product candidates in sufficient
quantities and at an acceptable cost, clinical development and commercialization
of its product candidates would be delayed; use of third-party manufacturers may
increase the risk that the Company will not have adequate supplies of its
product candidates; if third parties on whom the Company relies do not perform
as contractually required or expected, the Company may not be able to obtain
regulatory approval for or commercialize its product candidates; the Company is
dependent upon collaborative arrangements to complete the development and
commercialization of some of its product candidates, and these collaborative
arrangements may place the development of its product candidates outside its
control, may require it to relinquish important rights or may otherwise be on
terms unfavorable to the Company; 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 with the U.S. Securities and Exchange Commission (the
"SEC") on March 26, 2004 contains under the heading "Additional Factors That
Might Affect Future Results," 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.