Exhibit 99.1
Contact:
McDavid Stilwell
GTx, Inc.
Manager, Corporate Communications & Financial Analysis
901-523-9700
GTX REPORTS POSITIVE PHASE III TRIAL INTERIM ANALYSIS RESULTS
o Conference call scheduled for 10 a.m. EST to discuss the interim analysis o
MEMPHIS, TENN. - December 15, 2005 -- GTx, Inc. (Nasdaq: GTXI), the Men's Health
Biotech Company, today reported that men with prostate cancer on androgen
deprivation therapy (ADT) experienced highly statistically significant increases
in bone mineral density (BMD) after one year of treatment with ACAPODENE(R)
(toremifene citrate) 80 mg dose.
Patients treated with ACAPODENE demonstrated statistically significant increases
in BMD versus patients receiving placebo for each of the three different
skeletal sites measured. In lumbar spine, BMD increased +2.3% (p < 0.001); in
hip, +2% (p = 0.001); and in femoral neck, +1.5% (p=0.009), versus placebo.
The planned interim analysis of BMD, a secondary endpoint of the trial, was
conducted in accordance with a Special Protocol Assessment with the FDA for the
company's pivotal Phase III trial for the use of ACAPODENE, a selective estrogen
receptor modulator, or SERM, to treat the multiple serious side effects of ADT.
The analysis examined BMD in the first 200 patients to complete one full year of
treatment in order to give confidence that ACAPODENE would deliver at two years
the trial's primary endpoint, a 40% reduction in fractures. This interim
analysis is the largest prospective study reported to date of osteoporosis and
bone loss in men with hormone sensitive prostate cancer on ADT.
Matthew Smith, MD, PhD, an Associate Professor of Medicine at Harvard Medical
School, said "ACAPODENE's BMD changes are of a magnitude that should deliver the
desired fracture benefit, as they are consistent with BMD changes that have
translated into greater than 50% fracture reductions in other SERM trials of
post-menopausal women. I believe ACAPODENE will fill an important unmet medical
need, as there are no other FDA approved treatments available to reduce
fractures in men with hormone sensitive prostate cancer on ADT." Dr. Smith is a
lead physician investigator for GTx's ADT Phase III trial.
Mitchell Steiner, MD, CEO of GTx, said "Based on our Phase II data and the
supporting scientific literature, we expected ACAPODENE to build bone in men on
ADT. These results have confirmed the significant bone activity of ACAPODENE and
offer hope that ACAPODENE will reduce life threatening fractures in the
approximately 1 million men on ADT in the US. We also remain confident that our
Phase III trial of ACAPODENE will show benefits in the trial's other secondary
endpoints, including improvements in the lipid profile of the men receiving
ACAPODENE, as cardiovascular disease is a leading cause of death for men on
ADT."
Patients in the double blind, pivotal Phase III ADT trial are randomized to
receive daily either an 80 mg dose of toremifene citrate or matching placebo for
24 months. The primary endpoint of the trial is the occurrence of radiographic
vertebral fractures. Secondary endpoints include reduction of hot flashes and
improvement in gynecomastia, lipid profiles, bone mineral density, and quality
of life. 1,394 subjects are currently enrolled at 150 clinical sites in the
United States and Mexico. GTx reached its enrollment goal in the third quarter
of 2005.
CONFERENCE CALL
GTx will host a conference call this morning at 10 a.m. Eastern Standard Time to
review the data. Dr. Matthew Smith, a lead investigator of the Phase III trial,
will participate on the call along with members of GTx's senior management. To
listen to the conference call, please dial:
- 800-901-5213 from the United States and Canada or
- 617-786-2962 (International)
The access code for the call is 31470781.
A playback of the call will be available from approximately 2:00 p.m., Eastern
Time, on December 15 through December 29, and may be accessed by dialing:
- 888-286-8010 from the United States and Canada or
- 617-801-6888 (International), referencing reservation number
35973442.
Additionally, you may access the live and subsequently archived webcast of the
conference call from the Investor Relations section of the company's website at
http://www.gtxinc.com.
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 (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 the precancerous prostate lesion called high grade prostatic
intraepithelial neoplasia, or PIN. In its third clinical program, GTx is
developing ostarine for the treatment of acute muscle wasting conditions
associated with burns. GTx is also evaluating clinical development of ostarine
for the treatment of chronic muscle wasting conditions, such as testosterone
deficiency in aging men, or andropause. In its fourth clinical program, GTx and
its collaborating partner, Ortho Biotech Products, L.P., a subsidiary of Johnson
& Johnson, are developing andarine, another 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 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 will
not be able to commercialize its 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 its product candidates; (iii)
GTx's clinical trials 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 its 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 prospectus supplement filed with the U.S.
Securities and Exchange Commission (the "SEC") pursuant to Rule 424(b)(5) on
October 12, 2005, 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.