GTx, INC. - FORM 8-K
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): March 3, 2008
GTx, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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000-50549
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62-1715807 |
(Commission File Number)
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(IRS Employer Identification No.) |
3 N. Dunlap Street
Van Vleet Building
Memphis, Tennessee 38163
(Address of principal executive offices, including Zip Code)
Registrants telephone number, including area code: (901) 523-9700
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:
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 March 3, 2008, GTx, Inc., or GTx, issued a press release announcing additional 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 the release is furnished as Exhibit 99.1 to this Current Report.
GTx previously announced data from the Phase III ADT clinical trial demonstrating that toremifene
citrate 80 mg reduced new morphometric vertebral fractures, the primary endpoint of the trial, and
met other key endpoints, including increasing bone mineral density, improving lipid profiles and
ameliorating gynecomastia, as well as safety-related data, including the rate of venous
thromboembolic events (VTEs).
GTx has also completed an analysis of the effect of excluding patients over the age of 80 years and
with a history of VTEs from the modified intent to treat analysis of the primary endpoint, which
included all patients with at least one evaluable study radiograph and a minimum of one dose of
study drug or placebo. In this patient subset, the VTEs were 4 (1.3 %) in the toremifene citrate
80 mg treated group and 3 (1.0%) in the placebo group (p=0.679), and toremifene citrate 80 mg
demonstrated a 74% reduction in new morphometric vertebral fractures (p=0.008; 5.1% fracture rate
in the placebo group).
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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99.1 |
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Press Release issued by GTx, Inc. dated March 3, 2008. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, 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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Dated: March 3, 2008 |
By: |
/s/ Henry P. Doggrell
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Henry P. Doggrell |
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Vice President, General Counsel/Secretary |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press Release issued by GTx, Inc. dated March 3, 2008. |
EX-99.1 PRESS RELEASE
Exhibit 99.1
Contact:
McDavid Stilwell
GTx, Inc.
Director, Corporate Communications & Financial Analysis
901-523-9700
GTx Announces Additional Top Line Phase III Data Demonstrating
Toremifene Citrate 80 mg Reduced Hot Flashes in Men with Prostate Cancer on
Androgen Deprivation Therapy
The most common symptomatic side effect experienced by men on ADT is hot flashes
Memphis, TN March 3, 2008 GTx, Inc. (Nasdaq: GTXI) today announced that toremifene citrate 80
mg reduced hot flashes in men with prostate cancer on androgen deprivation therapy (ADT), a key
secondary endpoint of the Phase III clinical trial evaluating toremifene citrate 80 mg for the
treatment of multiple side effects of ADT for advanced prostate cancer.
In an analysis of hot flashes in a subset of patients in the Phase III ADT clinical trial
experiencing six or more hot flashes per day at baseline and not being treated with megestrol
acetate (Megace®), toremifene citrate 80 mg treatment reduced the number of hot flashes
by an average of 4.7 hot flashes per day compared to placebo patients who had a reduction of 1.6
hot flashes per day (p=0.03). The reduction of hot flashes in patients treated with toremifene
citrate 80 mg was durable for at least 12 months.
Hot flashes are the most common and bothersome symptomatic side effect of ADT. Up to 80% of men on
ADT report being troubled by hot flashes, which are often cited as a cause of noncompliance with
hormone therapy, 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.
GTx earlier announced data from the Phase III ADT clinical trial demonstrating that toremifene
citrate 80 mg reduced new morphometric vertebral fractures, the primary endpoint of the trial, and
met other key endpoints, including increasing bone mineral density, improving lipid profiles, and
ameliorating gynecomastia.
The Phase III ADT clinical trial data are important because they demonstrate the potential for
toremifene citrate 80 mg as a treatment for multiple side effects of ADT, reducing fractures and
improving lipid profiles while also treating symptomatic side effects such as hot flashes and
gynecomastia, added Dr. Smith.
These hot flashes data provide additional confirmation that the multiple estrogen related side
effects of androgen deprivation therapy for prostate cancer are treatable by toremifene citrate 80
mg, which binds to and selectively modulates the estrogen receptor depending on tissue type, said
Mitchell S. Steiner, MD, Chief Executive Officer of GTx.
Toremifene citrate 80 mg had a favorable safety profile and was well tolerated. Among the most
common adverse events that occurred 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%).
Conference Call
There will be a conference call today at 9:00 a.m. Eastern Time. GTx and Dr. Smith will discuss the
top line results of the toremifene citrate 80 mg Phase III ADT clinical trial. To listen to the
conference call, please dial 866-770-7051 from the United States or Canada or 617-213-8064 from
outside North America. The access code for the call is 82373052. A playback of the call will be
available from approximately 11:00 a.m., Eastern Time today through March 10, 2008 and may be
accessed by dialing 888-286-8010 from the United States or Canada or 617-801-6888 from outside
North America, and referencing reservation number 39648500. Additionally, you may access the live
and subsequently archived webcast of the conference call from the Investor Relations section of the
Companys website at http://www.gtxinc.com.
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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