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 PHASE I CLINICAL TRIAL
FOR ITS SECOND SARM OSTARINE
Memphis, Tenn.--February 1, 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 it has
initiated a Phase I clinical trial for ostarine, GTx's second selective androgen
receptor modulator (SARM) compound to be tested in clinical trials.
"We are very excited about the promising preclinical ostarine data and are
pleased to initiate this clinical trial," stated Mitchell Steiner, M.D., Vice
Chairman and CEO of GTx. "This shows that we have the proven ability to create
compounds in the laboratory and move them into the clinic as we continue to
position GTx as the lead SARM company."
The Phase I study will evaluate the safety, tolerability and pharmacokinetic
profile of ostarine using a single ascending dose, double-blind,
placebo-controlled design in healthy volunteers.
Ostarine is a nonsteroidal SARM that is designed to have positive anabolic
effects without having an impact on the prostate and is being developed for
andropause as well as other conditions associated with aging, such as
sarcopenia. Sarcopenia is defined as the loss of muscle mass associated with
aging leading to frailty and loss of independence.
As people age they undergo hormonal and metabolic changes. Each year after age
30 people gain an average of a pound of fat every year and lose a half a pound
of muscle every year. Thus, men may lose 50% of muscle between the ages of 30
and 90. Muscle provides strength and endurance, supports the skeletal system and
helps protect the body from illness. Loss of muscle can cause frailty, loss of
independence, and worsens other conditions such as osteoarthritis and
osteoporosis. There are 17 million Americans alive over the age of 75 who suffer
from sarcopenia and currently there are no approved treatment options available.
GTx's SARM Discovery Program
GTx believes that the ability to selectively target and modulate the androgen
receptor will allow the development of many new drugs that are crucial for men's
health. In fact, different compounds within the SARM class have demonstrated in
preclinical studies unique pharmacologic activities, with varying effects on
endocrine feedback, prostatic stimulation, spermatogenesis, muscle growth, bone
growth and sexual behavior, highlighting the untapped potential of these novel
drugs for treatment of other diseases, including benign prostatic hyperplasia
(BPH), male infertility, and low libido.
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 ostarine 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.