GTx, Inc. (NASDAQ: GTXI) announced today that its poster presentation entitled, “GTx-758, an ERα agonist, reduces serum free testosterone lower than can be achieved by leuprolide with a significantly lower rate of hot flashes in men with advanced prostate cancer”, was selected as one of the best posters at the 28 th Annual European Association of Urology Congress held in Milan, Italy, which commenced March 15, 2013. The presentation was held on Saturday, March 16, 2013 in Milan, Italy, in the session on new therapies in castration resistant prostate cancer. The data being presented represents findings from completed Phase II clinical studies of men with advanced prostate cancer examining the ability of GTx-758 (Capesaris ®) to further reduce the levels of unbound, or “free”, testosterone to potentially limit the cancer’s advancement to castration resistant prostate cancer. Even with maximal suppression of free testosterone, GTx-758 may also, by replacing estrogen, provide the prospect for an improved quality of life with a better side effect profile than what is more typically experienced by men with advanced prostate cancer treated with commonly utilized forms of androgen deprivation therapy. GTx is currently enrolling a Phase II clinical study (G200712) to evaluate the safety and effectiveness of lower doses of GTx-758 to treat men with metastatic castration resistant prostate cancer and expects to receive topline data from this study later this year.
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 UncertaintyThis 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 clinical studies of GTx-758. 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-K filed with the Securities and Exchange Commission on March 5, 2013 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.