GTx Announces Presentation of Acapodene Data At ASCO Prostate Cancer SymposiumMEMPHIS, Tenn.--(BUSINESS WIRE)--Feb 21, 2007 - GTx, Inc. (Nasdaq: GTXI), today announced that Phase III data from a bone mineral density interim analysis and from a lipid interim analysis will be presented in separate podium sessions on February 23rd at the American Society of Clinical Oncology Prostate Cancer Symposium. Both analyses were conducted in the first 197 men to complete one year of treatment in the Phase III clinical trial evaluating ACAPODENE(R) (toremifene citrate) 80 mg for the treatment of multiple serious side effects of androgen deprivation therapy (ADT) for advanced prostate cancer.
Dr. S. Bruce Malkowicz, Professor of Urology at the University of Pennsylvania School of Medicine, will present the bone mineral density interim data, and Dr. Matthew Smith, Associate Professor at Massachusetts General Hospital Cancer Center, will present the lipid interim data. The presentations will be delivered in an Oral Abstract Session beginning at 1 p.m. on February 23rd in the Osceola Ballroom at the Gaylord Palms Resort & Conference Center in Orlando, Florida.
GTx has been notified that these presentations have been selected to be part of an ASCO press briefing the morning of February 23rd.
GTx is conducting the Phase III ADT clinical trial in approximately 1,400 patients at nearly 150 clinical sites in the United States and Mexico. The primary endpoint of the pivotal Phase III ADT clinical trial is a reduction in vertebral morphometric fractures. Secondary endpoints include improvements in BMD, hot flashes, gynecomastia, and lipid profiles. The last patient will complete the trial at the end of November, 2007. GTx will then evaluate the data and prepare it for public release. If the data demonstrate a significant fracture benefit, GTx will file a new drug application in 2008.
GTx, headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics for cancer and serious conditions related to men's health. GTx's lead drug discovery and development programs are focused on small molecules that selectively modulate the effects of estrogens and androgens. GTx is developing ACAPODENE(R) (toremifene citrate), a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: first, a pivotal Phase III clinical trial for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer, and second, a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. GTx has licensed to Ipsen Limited exclusive rights in Europe to develop and commercialize ACAPODENE(R). GTx also is developing ostarine, a first-in-class selective androgen receptor modulator, or SARM. GTx plans to initiate a Phase IIb ostarine clinical trial for cancer cachexia by the summer of 2007. GTx plans to initiate a Phase IIb ostarine clinical trial for the treatment of chronic kidney disease and end stage renal disease muscle wasting by the end of 2007. GTx believes that ostarine also has the potential to treat a variety of other indications associated with muscle wasting and bone loss including frailty and osteoporosis.
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. 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 that (i) GTx will not be able to commercialize its 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 its product candidates; (iii) GTx's clinical trials 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 its 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. GTx's prospectus supplement filed with the U.S. Securities and Exchange Commission (the "SEC") pursuant to Rule 424(b)(5) on December 13, 2006, 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.
Director, Corporate Communications & Financial Analysis:
McDavid Stilwell, 901-523-9700
Posted: February 2007