GTx, Inc. Announces ENDO 2006 Presentations Of Preclinical SARM Studies

MEMPHIS, Tenn., June 21 /PRNewswire-FirstCall/ -- GTx, Inc. , the Men's Health Biotech Company, today announced the upcoming presentations of preclinical studies describing the bone promoting activities and defining the possible mechanisms for the tissue selectivity of its selective androgen receptor modulators (SARMs) at ENDO 2006, the 88th Annual Meeting of the Endocrine Society, in Boston on June 26 & 27.

SARMs are small molecules that are orally available, bind to the androgen receptor, and exhibit tissue selective anabolic activity on bone and muscle without unwanted androgenic effects on the prostate and skin. GTx has progressed two SARMs, ostarine and andarine, into clinical development. In May 2006, GTx initiated a proof of concept Phase II clinical trial of ostarine, a first-in-class drug. The three month placebo controlled clinical trial is evaluating multiple doses of ostarine in 60 elderly men and 60 postmenopausal women. The trial is designed to evaluate the activity of ostarine on building muscle and promoting bone as well as assessing safety in both elderly men and postmenopausal women. GTx expects to report data from this comprehensive proof of concept Phase II clinical trial in the second half of 2006.

The schedule and meeting places for the ENDO 2006 sessions, together with abstract number, are listed below:

Session information: ORAL SESSION: BASIC -- Steroid Hormone Action II (1:15 PM-2:45 PM), June 27, 2006

Abstract # OR49-1

"Molecular Mechanism for the Tissue Selectivity of a Novel Non-Steroidal Selective Androgen Receptor Modulator: Genome-Wide Mapping of Androgen Receptor Binding Sites."

Presenter: R. Narayanan, Ph.D.

Location: Room 160, Boston Convention and Exhibition Center

Session information: POSTER SESSION: BASIC -- Vitamin D, Sex Steroids & Nutrition (11:00 AM-12:00 PM and 2:30 PM-3:30 PM), June 26, 2006

Poster Board # P3-64

"Preclinical Pharmacology of a Novel Osteoanabolic Tissue Selective Androgen Receptor Modulator."

Presenter: J. Kearbey, Ph.D. Location: Exhibit Hall, Boston Convention and Exhibition Center About GTx

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 Quarterly Report on Form 10-Q filed on May 5, 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.

CONTACT: McDavid Stilwell, Manager, Corporate Communications & FinancialAnalysis of GTx, Inc., +1-901-523-9700

Web site: http://www.gtxinc.com/