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GTx Announces Presentation on the Ability of Capesaris to Reduce Free Testosterone and Suppress PSA in Men With Castration Resistant Prostate Cancer

MEMPHIS, Tenn.--(BUSINESS WIRE)--Sep 19, 2012 - GTx, Inc. (Nasdaq: GTXI) announced today there will be a presentation on the mechanism of action of Capesaris® to induce sex hormone binding globulin (SHBG) and subsequently reduce free testosterone (FT) in men with castration resistant prostate cancer. On September 29, 2012, between 1:00 and 2:00pm Vienna time, at the European Society for Medical Oncology (ESMO) 2012 to be held in Vienna, Austria from September 28 through October 2, 2012, GTx will make a presentation entitled: “GTx-758, an Oral ERα Agonist, Increases Sex Hormone Binding Globulin, Reduces Free T and Decreases PSA in Patients With Castration Resistant Prostate Cancer.”

Mitchell S. Steiner, MD, Vice-Chairman and CEO of GTx, will present data from the company's Phase II G200707 clinical study of Capesaris providing evidence that Capesaris increases SHBG, decreases FT, and reduces serum PSA. In another recent Phase II clinical study conducted by GTx (G200705) in men with advanced prostate cancer who were hormone naïve, a significant reduction in FT was observed in Capesaris treated subjects in comparison to those treated with Lupron®, a LHRH agonist for the treatment of advance prostate cancer. The Phase II clinical studies were stopped early due to an increased risk of venous thromboembolic events (VTEs) at the higher Capesaris doses used in these previous clinical studies. However, clinical data from Phase I and Phase II studies suggest that significant increases in serum SHBG, and corresponding reductions in FT, can be achieved with lower (125 to 500 mg) doses of Capesaris.

GTx has initiated a new Phase II clinical trial (G200712) to evaluate the safety and effectiveness of lower doses of Capesaris to treat men with metastatic castration resistant prostate cancer. Seventy-five men with metastatic castration resistant prostate cancer will be randomized into one of three cohorts to receive a 125 mg, 250 mg or 500 mg daily dose of Capesaris. Each arm will have 25 subjects and the enrollment will be conducted sequentially, with the 125 mg cohort being the first to be enrolled. The enrollment into the next higher dose of Capesaris will commence if an acceptable incidence of VTEs is observed among randomized patients for 30 days following enrollment of the last patient in the previous cohort. The primary endpoint will be to lower serum PSA by ‰¥ 50% by day 90. Other key cancer endpoints include serum PSA progression, time to progression and progression free survival in these study subjects. In addition, the study will evaluate the ability of Capesaris to treat certain estrogen deficiency side effects associated with medical castration such as hot flashes, bone loss, and insulin resistance.

About GTx

GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules for the treatment of cancer, cancer supportive care and other serious medical conditions.

Forward-Looking Information is Subject to Risk and Uncertainty

This press release contains forward-looking statements based upon GTx's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements relating to its planned clinical trials. 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, the risks (i) that GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; (iii) that clinical trials being conducted by GTx may not be completed on schedule, or at all, or may otherwise be suspended or terminated; or (iv) 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. GTx's annual report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2012 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.


Contact: GTx, Inc.
Marc Hanover, President, 901-523-9700



Posted: September 2012