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. |