GTx Announces Presentation of Ostarine and Acapodene Data at 2007 ASCO Annual Meeting
William J. Evans, PhD, Professor of Geriatrics, Physiology, and Nutrition at the Donald W. Reynolds Institute on Aging at the University of Arkansas for Medical Sciences, will present the results of a Phase II proof of concept clinical trial evaluating the effects of Ostarine treatment on lean body mass and functional performance in 120 elderly males and postmenopausal females.
-- "Ostarine increases lean body mass and improves physical performance in healthy elderly subjects: Implications for cancer cachexia patients." Poster number: MM2. Abstract number: 9119.
-- Date and time: June 2, 2007 from 2:00 to 6:00 p.m.
-- Location: S Hall A2
Matthew R. Smith, MD, PhD, Associate Professor of Medicine at Harvard Medical School and the Lead Principal Investigator of the Phase III ADT clinical trial, will present results of an interim lipid analysis conducted in the first 197 men to complete one year of the trial.
-- "Effect of toremifene in lowering total cholesterol, LDL, and triglycerides and raising HDL in prostate cancer patients on androgen deprivation therapy." Poster number: G6. Abstract number: 5124.
-- Date and time: June 3, 2007 from 2:00 to 6:00 p.m.
-- Location: S Hall A2
S. Bruce Malkowicz, MD, Professor of Surgery at University of Pennsylvania School of Medicine, will present data detailing the prevalence at baseline of bone loss in patients participating in the Phase III ADT clinical trial.
-- "Prevalence of osteoporosis and osteopenia during androgen deprivation therapy (ADT) for prostate cancer: Baseline data from a large randomized controlled trial." Poster number: F5. Abstract number: 5116.
-- Date and time: June 3, 2007 from 2:00 to 6:00 p.m.
-- Location: S Hall A2
About GTx
GTx, headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions. 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(TM), a first-in-class selective androgen receptor modulator, or SARM. GTx plans to initiate a Phase IIb Ostarine(TM) clinical trial for cancer cachexia in non-small cell lung cancer patients in June of 2007. GTx plans to initiate a Phase IIb Ostarine(TM) clinical trial for the treatment of chronic kidney disease muscle wasting by the end of 2007. GTx believes that Ostarine(TM) also has the potential to treat a variety of other indications associated with muscle wasting and bone loss including sarcopenia 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 be 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 it 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 quarterly report on form 10-Q filed with the U.S. Securities and Exchange Commission on May 7, 2007, 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., Memphis
McDavid Stilwell, 901-523-9700
Director, Corporate Communications & Financial Analysis
Posted: May 2007
