MEMPHIS, Tenn., May 3 /PRNewswire-FirstCall/ -- GTx, Inc. , the Men’s Health Biotech Company, announced today that it has attained its enrollment goal for the pivotal Phase III clinical trial of ACAPODENE(R) for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia, or PIN. This is the largest ever prospective study of high grade PIN, with more than 1,260 men participating in the placebo-controlled, double blind clinical trial.
“The fact that we have been able to enroll this large clinical trial in about 15 months demonstrates that these patients and their physicians recognize that men with high grade PIN are at high risk for developing prostate cancer,” said Mitchell S. Steiner, M.D., Chief Executive Officer of GTx. “As multiple prospective studies have demonstrated, up to 50% of these patients may develop prostate cancer within three years, and between five and eight years the risk rises to 80 percent.”
More than 150 clinical sites in the United States, Canada, Mexico and Argentina have been enrolling patients for this trial. To participate in the trial, patients must have a diagnosis of high grade PIN confirmed by a central pathologist, David Bostwick, M.D. Patients in the clinical trial were randomized to receive daily for three years either ACAPODENE (toremifene citrate) in a 20 mg dose or placebo. The primary endpoint of the trial is a reduction in prostate cancer incidence. The trial is being conducted under a Special Protocol Assessment with the United States Food & Drug Administration. The trial is designed as a 36 month study but provides for an interim efficacy analysis after a sufficient number of cancer events have occurred. GTx believes an interim analysis of the trial results will occur in the fourth quarter of 2007 or the first quarter of 2008. If the efficacy endpoint is statistically achieved, GTx plans to file a new drug application with the FDA during 2008.
About GTx, Inc.
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, two essential classes of hormones. 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 also is developing ostarine, a selective androgen receptor modulator, or SARM, for a variety of indications including muscle wasting and bone loss in frail elderly patients, osteoporosis, muscle wasting in end stage renal disease patients, and severe burn wounds and associated muscle wasting. GTx has licensed to Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, another of its SARMs, andarine, under a joint collaboration and license agreement.
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 Annual Report on Form 10-K filed on March 2, 2006 contains 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.
GTx, Inc.
CONTACT: McDavid Stilwell of GTx, Inc., Manager, Corporate Communications& Financial Analysis, +1-901-523-9700
Web site: http://www.gtxinc.com/
