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GTx Announces Upcoming AUA Presentation of Additional Study Results from the Phase III Clinical Trial Evaluating Toremifene 80

^{Published on 2010-05-27 04:10:48 - Market Wire}
 

MEMPHIS, Tenn.--([ BUSINESS WIRE ])--GTx, Inc. (NASDAQ: GTXI) today announced that additional study results from the Phase III clinical trial evaluating toremifene 80 mg for the prevention of fractures in men with prostate cancer on androgen deprivation therapy will be presented at the 2010 Annual Meeting of the American Urological Association being held in San Francisco May 29-June 3.

"Toremifene improves PSA progression free survival in castrate men with detectable baseline PSA levels"

Podium presentation: aToremifene improves PSA progression free survival in castrate men with detectable baseline PSA levelsa

• Sunday, May 30, 2010, 3:30 a" 5:30 p.m.
• Moscone South, Room 104

Moderated poster presentation: aMultivariate analysis demonstrates treatment with toremifene 80 mg reduces fracture risk after initiation of androgen deprivation therapya

• Monday, May 31, 2010, 10:30 a.m. a" 12:30 p.m.
• Moscone North, Room 130-131

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 for the treatment and prevention of cancer, the treatment of side effects of anticancer therapy, cancer supportive care, and other serious medical conditions.

GTx is developing toremifene 80 mg for the reduction of fractures and treatment of other estrogen deficiency side effects of androgen deprivation therapy for prostate cancer. GTx has completed a successful toremifene 80 mg Phase III clinical trial and expects to initiate TREAT 2, the second Phase III clinical trial by year end 2010.

GTx is also developing Ostarinea" (GTx-024) and other selective androgen receptor modulators, or SARMs, for cancer cachexia and other muscle wasting diseases. GTx is meeting with the FDA this summer to discuss the late stage clinical development plan for Ostarine for cancer cachexia.

GTxa™s newest product candidate is GTx-758, an oral LH inhibitor, which is in a Phase II clinical trial. GTx-758 has the potential to achieve medical castration without causing bone loss, hot flashes, impotence and other serious side effects of currently available androgen deprivation therapy for prostate cancer. GTx expects to receive results of the Phase II clinical trial this summer.

Forward-Looking Information is Subject to Risk and Uncertainty

This press release contains forward-looking statements based upon GTxa™s current expectations. Forward-looking statements include, but are not limited to, statements relating to GTxa™s plans to continue to pursue the development of and marketing approval for, and the potential commercialization of, toremifene 80 mg, and the continued development and potential commercialization of GTxa™s other product candidates. Forward-looking statements involve risks and uncertainties. GTxa™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, the risks (i) that GTx and its collaboration partner will not be able to commercialize their product candidates if clinical trials do not demonstrate safety and efficacy in humans, including in any additional clinical trials that GTx may conduct for toremifene 80 mg to reduce fractures in men with prostate cancer on ADT; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates, including toremifene 80 mg to reduce fractures in men with prostate cancer on ADT, in a timely manner or at all; (iii) that clinical trials being conducted or planned to be conducted by GTx and its collaboration partner may not be initiated or completed on schedule, or at all, or may otherwise be suspended or terminated; (iv) related to GTxa™s dependence on its collaboration partner for product candidate development and commercialization efforts; (v) related to GTxa™s reliance on third parties to manufacture its product candidates and to conduct its clinical trials; and (vi) that 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 candidate 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. GTxa™s annual report on Form 10-Q filed with the SEC on May 4, 2010 contains under the heading, aRisk Factors,a 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.