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Contact:
GTx, Inc. Carney Duntsch
Investor and Media Relations
901-523-9700 ext. 170
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Burns McClellan, Inc.
Jonathan M. Nugent (investors)
Kathy L. Jones-Nugent, Ph.D. (media)
212-213-0006 |
GTx, Inc. Collaborates with Tessera, Inc. to
Develop a Diagnostic Test to Detect High Grade PIN
Memphis, Tenn.—July 27, 2004— GTx,
Inc., (Nasdaq: GTXI) a biopharmaceutical company dedicated to the
discovery, development and commercialization of therapeutics primarily
related to the treatment of serious men's health conditions, announced
today that it has entered into a collaboration with Tessera, Inc.
Under the terms of the agreement GTx will provide clinical samples
from its completed Phase IIb clinical trial program which evaluated
ACAPODENE™ (toremifene citrate) for the reduction in the incidence
of prostate cancer in men with high grade prostatic intraepithelial
neoplasia (PIN), a premalignant lesion that has the potential to
progress to prostate cancer. ACAPODENE™ is a nonsteroidal
SERM (selective estrogen receptor modulator) that appears to block
the estrogen's unwanted actions on the prostate.
The collaboration will focus on the development of
a commercial blood or urine test which could detect high grade PIN
in the millions of men who unknowingly harbor this precancerous
lesion of the prostate or who may develop prostate cancer.
"Currently, there is an estimated 9.4 million
men in the U.S. alone that unknowingly harbor high grade PIN, but
on average, only 115,000 of these men will be diagnosed each year,"
says Mitchell Steiner, M.D., CEO of GTx. "When a blood or serum
test to detect PIN is discovered, we believe ACAPODENE can provide
this large number of men who are at high risk for developing prostate
cancer the opportunity to reduce the risk that they will develop
this disease."
Dr. Robert Masterson, President/CEO of Tessera, states,
"The partnership with GTx is to evaluate the use of Tessera's ProstaMark»
EPCA (Early Prostate Cancer Antigen) to identify patients with PIN
lesions and/or early stage prostate cancer. Theranostics, which
is the use of a diagnostic with a disease therapy, is the wave of
the future in healthcare and specifically in cancer treatment."
Dr. Masterson also comments, "Tessera is very excited with the opportunity
to work closely with Dr. Steiner and the extremely qualified and
talented group of scientists at GTx, Inc."
About high grade PIN
High grade PIN has been established as a premalignant lesion of
the prostate that has a high potential to progress to invasive prostate
cancer. Men who harbor PIN are thought to be at greater risk for
developing prostate cancer within ten years. Unfortunately, today
high grade PIN diagnosis is only detected when men are biopsied.
GTx sees a great need for a diagnostic blood or urine marker that
will provide a simple, but effective way of detecting PIN and/or
prostate cancer. This year in the United States, approximately 1,300,000
prostate biopsies will be performed to detect over 230,000 new cases
of prostate cancer. High grade PIN is found in an average of 9%
of prostate biopsies which represents an estimated 115,000 new cases
of high grade PIN diagnosed each year. Patients who are found to
have high grade PIN are at high risk of prostate cancer with up
to 37% of patients being later diagnosed with prostate cancer within
1 year.
High grade PIN clinical development
overview
On June 4, 2004, GTx announced positive Phase IIb clinical trial
results for its lead program ACAPODENE™. The ACAPODENE™
Phase IIb study was a double-blind, placebo-controlled, one-year
clinical trial in 514 men with high grade PIN who are at high risk
for prostate cancer. The primary endpoint was the incidence of prostate
cancer. This is the largest prospective study to determine the natural
history of patients with high grade PIN and supports the premise
that high grade PIN patients have a high risk for developing prostate
cancer. The study also suggests that ACAPODENE™ may be a highly
effective agent in preventing prostate cancer. Specifically, the
trial demonstrated that ACAPODENE™ 20mg can produce a clinically
significant reduction of prostate cancer cumulative risk over one
year. Patients treated with ACAPODENE™ 20mg had a lower incidence
of prostate cancer compared to placebo, 24.4% vs. 31.2% respectively.
Furthermore, the data appears to suggest that the longer men with
high grade PIN are treated with ACAPODENE™, the greater the
likelihood that their risk of prostate cancer is reduced. The study
revealed that patients who were treated with ACAPODENE™ for
the entire 12 months had a 48% reduction in prostate cancer incidence.
The study also demonstrated that ACAPODENE™ was well tolerated
by patients compared to placebo. Following discussions with the
Food and Drug Administration (FDA), GTx plans to initiate a pivotal
Phase III clinical trial to confirm these positive findings.
About ACAPODENE™
Toremifene 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™ tablets, worldwide in the
field of prevention and treatment of prostate cancer from Orion
Corporation, Finland.
About GTx
GTx, Inc. is a biopharmaceutical company dedicated to the discovery,
development and commercialization of therapeutics primarily related
to the treatment of 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 has two clinical programs: In the first clinical program, GTx
is developing ACAPODENE™, its most advanced product candidate
for two separate indications: (1) a pivotal Phase III clinical trial
for the treatment of serious side effects of advanced prostate cancer
therapy and (2) its completed Phase IIb clinical trial for the reduction
in the incidence of prostate cancer in high risk men with precancerous
prostate lesions. In the second clinical program, GTx is developing
andarine, and other specified backup compounds, with its partner,
Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson.
Andarine will be entering a planned Phase II clinical trial this
year. GTx retains all rights to the discovery, development, and
commercialization of the rest of its SARM program including its
other specific product candidates ostarine, prostarine and andromustine.
About Tessera, Inc.
Tessera, Inc. (Seattle, WA) was incorporated in 2000 by Dr. Robert
Masterson and H. Raymond Cairncross as a biomedical company committed
to the discovery and commercialization of effective products for
the early detection of prostate and colon (or colorectal) cancer.
Through its exclusive, worldwide licensing arrangements with both
Johns Hopkins University School of Medicine and the University of
Pittsburgh Department of Urology, Tessera has obtained rights to
the use and development to date of more than 60 protein markers
not only for the early diagnosis of these often lethal cancers but
also for drug screening and "in vivo" imaging. ProstaMark™
EPCA is the first of potentially many early detection products to
be developed and commercialized.
Forward Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to GTx's current and anticipated
clinical trials of ACAPODENE™ 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 neither GTx nor its collaboration
partners 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 the press release. The annual report
filed on Form 10-K with the U.S. Securities and Exchange Commission
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.
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