GTx, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 25, 2008
GTx, Inc.
(Exact name of Registrant as specified in its charter)
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Delaware
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005-79588
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62-1715807 |
(State or other jurisdiction of
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(Commission
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(I.R.S. Employer |
incorporation or organization)
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File Number)
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Identification No.) |
3 N. Dunlap Street
Van Vleet Building
Memphis, Tennessee 38163
(901) 523-9700
(Address, including zip code, of Registrants principal executive offices
Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM 8.01 Other Events.
On February 25, 2008, GTx, Inc. issued a press release announcing positive Phase III
clinical trial results for toremifene citrate 80 mg, the Companys investigational
therapy for the treatment of multiple side effects of androgen deprivation therapy
(ADT) for advanced prostate cancer, a copy of which is furnished as Exhibit 99.1 to
this Current Report.
ITEM 9.01 Financial Statements and Exhibits.
(c) Exhibits
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Exhibit |
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Number |
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Description |
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99.1 |
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Press Release issued by GTx, Inc. dated February 25, 2008 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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GTx, Inc.
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Date: February 25, 2008 |
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/s/ Henry P. Doggrell
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Name: |
Henry P. Doggrell |
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Title: |
Vice President, General Counsel/Secretary |
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EX-99.1 Press Release
Exhibit 99.1
Contact:
McDavid Stilwell
GTx, Inc.
Director, Corporate Communications & Financial Analysis
901-523-9700
GTxs Toremifene Citrate 80 mg Meets Primary and Key Endpoints in Phase III Trial in
Advanced Prostate Cancer Patients on Androgen Deprivation Therapy
Results Show a 50 Percent Reduction in Incidence of Androgen Deprivation Induced
Osteoporosis Related Vertebral Fractures
Memphis, TN February 25, 2008 GTx, Inc. (Nasdaq: GTXI) today announced Phase III clinical
data for toremifene citrate 80 mg, the Companys investigational therapy for the treatment of
multiple side effects of androgen deprivation therapy (ADT) for advanced prostate cancer. Results
show that toremifene citrate 80 mg reduced vertebral fractures and met other key endpoints,
including bone mineral density, lipid profiles, and gynecomastia.
Based on these findings, GTx plans to file a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) by the summer of 2008. In addition, GTx plans to present the full data set at
an upcoming medical meeting.
The toremifene citrate 80 mg Phase III ADT clinical trial is the first fracture prevention study
in men receiving ADT for prostate cancer. The study confirms that men receiving ADT are at high
risk for fractures. The rate of vertebral fracture in the placebo group in this study was about 10
times greater than that expected for men of a similar age not receiving ADT, as reported in other
studies, said Matthew R. Smith, MD, PhD, Director, Genitourinary Medical Oncology, Massachusetts
General Hospital Cancer Center, Associate Professor of Medicine at Harvard Medical School, and Lead
Principal Investigator of the Phase III ADT clinical trial.
Androgen deprivation therapy is the cornerstone treatment for men with advanced prostate cancer,
but has been associated with serious side effects. The results from this exciting study demonstrate
that toremifene citrate 80 mg reduced fractures and other side effects in men taking ADT, added
Dr. Smith.
About the Disease
Androgen deprivation therapy is the most common treatment for advanced prostate cancer, used in
approximately 800,000 men. ADT (e.g. leuprolide/triptorelin injections) is hormone therapy that
works by reducing testosterone and estrogen. This may result in multiple estrogen related side
effects, including bone loss and fractures, hot flashes, lipid changes and increased cardiovascular
risk, and gynecomastia. Studies have shown that men on ADT are at risk for fractures, and ADT
patients who develop a fracture have a 39 month shorter median survival. ADT has also been
associated with increased risk of cardiovascular disease and death. There are no drugs approved by
the FDA to treat multiple side effects of ADT for prostate cancer. Men with prostate cancer of a
similar age who are not on ADT have a vertebral fracture rate of approximately 0.3% over two years.
About the Study
The two year double-blind, placebo-controlled study randomized 1,389 ADT patients at approximately
150 clinical sites in the United States and Mexico. The primary endpoint was new morphometric
vertebral fractures read by an independent third party. Other key endpoints included bone mineral
density, lipid changes, hot flashes, and gynecomastia.
Fracture endpoints
In a modified intent to treat analysis which included all patients with at least one evaluable
study radiograph and a minimum of one dose of study drug or placebo, toremifene citrate 80 mg
demonstrated a 50% reduction in morphometric vertebral fractures (p<0.05; 5% fracture rate in
the placebo group). The estimated two year fracture rate for new morphometric vertebral fractures
in the placebo group was 6.2%. In an intent to treat analysis which included all patients
randomized into the trial, toremifene citrate 80 mg demonstrated a 53% reduction in new
morphometric vertebral fractures (p=0.034; 3.6% fracture rate in the placebo group).
In prespecified subset analyses, in study patients who were greater than 80% treatment compliant,
toremifene citrate 80 mg reduced vertebral morphometric fractures by 61% (p=0.017). When study
patients who had greater than 7% bone loss at one year and new morphometric vertebral fractures
were considered as treatment failures, toremifene citrate 80 mg compared to placebo demonstrated a
56% reduction (p=0.003).
Other key endpoints
Patients treated with toremifene citrate 80 mg compared to placebo demonstrated statistically
significant increases in bone mineral density in the lumbar spine, hip, and femur skeletal sites
(each site demonstrating p<0.0001). Toremifene citrate 80 mg treatment compared to placebo also
resulted in a decrease in total cholesterol (p=0.011), LDL (p=0.018), and triglycerides
(p<0.0001), and an increase in HDL (p=0.001). There were also statistically significant
improvements in gynecomastia (p=0.003). As for the effect of toremifene citrate 80 mg on hot
flashes, the evaluation of these data is still ongoing and will be reviewed with the final data
set.
Safety
Toremifene citrate 80 mg had a favorable safety profile and was well tolerated. Among the most
common adverse events that occurred in over 2% of study subjects were joint pain (treated 7.3%,
placebo 11.8%), dizziness (treated 6.3%, placebo 5.0%), back pain (treated 5.9%, placebo 5.2%), and
extremity pain (treated 5.0%, placebo 4.4%).
Venous thromboembolic events (VTE), which included both deep venous thrombosis and pulmonary
embolism, were 17 (2.4 %) in the toremifene citrate 80 mg treated group and 7 (1.02 %) in the
placebo group. The majority of VTEs occurred in men at high risk for a VTE including: age >80
years, history of VTE, recent surgical procedure and immobilization. In men without major risk
factors for VTE, there were 3 VTE in the toremifene citrate 80 mg treated group and 2 VTE in the
placebo group. The most significant VTE risk occurred in the first year of treatment. In year two,
the VTE event rate in the toremifene citrate 80 mg treated group was similar to the rate observed
in the placebo group.
GTx has successfully reached an important corporate milestone event by meeting the primary and key
secondary objectives of the Phase III ADT clinical trial, said Dr. Mitchell Steiner, Chief
Executive Officer of GTx. We now can move forward with our plans to prepare and submit the NDA for
toremifene citrate 80 mg.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the
discovery, development, and commercialization of small molecules that selectively target hormone
pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical
conditions.
GTx is developing ACAPODENE® (toremifene citrate), a selective estrogen receptor
modulator, or SERM, in two separate clinical programs in men: first, a pivotal Phase III clinical
trial evaluating toremifene citrate 80 mg for the treatment of serious side effects of androgen
deprivation therapy for advanced prostate cancer, and second, a pivotal Phase III clinical trial
evaluating toremifene citrate 20 mg for the prevention of prostate cancer in high risk men with
high grade prostatic intraepithelial neoplasia, or PIN.
GTx licensed from Orion Corporation the rights to toremifene citrate for all indications worldwide,
except breast cancer outside the United States. In 2006, GTx and Ipsen Group entered into a
development and collaboration agreement for toremifene citrate in all indications except breast
cancer for Europe and the Commonwealth of Independent States (CIS). Ipsen is the leading marketer
of ADT (triptorelin) in Europe. Under the agreement, Ipsen will be responsible for filing for
marketing approval with regulatory authorities and commercializing toremifene citrate in Europe and
CIS. GTx will file for marketing approval and plans to commercialize toremifene citrate 80 mg in
the United States.
GTx has formed a strategic collaboration with Merck & Co., Inc. for the development and global
commercialization of selective androgen receptor modulators, or SARMs, a new class of drugs with
the potential to treat a variety of indications associated with muscle wasting and bone loss,
including frailty or sarcopenia, muscle wasting associated with chronic diseases, osteoporosis, and
cancer cachexia. GTx also has announced that it is developing its preclinical compounds, GTx-758,
an oral LH inhibitor for advanced prostate cancer, and GTx-878, an estrogen receptor beta agonist
for the treatment of benign prostatic hyperplasia and chronic prostatitis.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTxs current expectations.
Forward-looking statements involve risks and uncertainties. GTxs 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
and its collaboration partners will not be able to commercialize their 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 product candidates; (iii) clinical trials being
conducted by GTx and its collaboration partners 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 it 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. GTxs registration statement on Form S-3 (file no. 333-148325) filed
December 26, 2007 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.
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