PHILADELPHIA and MEMPHIS, Tenn., March 31 /PRNewswire-FirstCall/ -- MacroArray Technologies, LLC, and GTx, Inc., today announced that MacroArray Technologies will present data from its development of a urine test for prostatic intraepithelial neoplasia (PIN) in a poster session at the upcoming Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington D.C. April 1-5, 2006.
The poster provides details of MacroArray’s development of a novel urine-based diagnostic test for high grade PIN, a premalignant lesion of the prostate. GTx supplied to MacroArray urine and serum samples from patients with high grade PIN enrolled in Phase IIb and Phase III clinical trials to assist MacroArray in its development and validation of a noninvasive test for high grade PIN. GTx is conducting a pivotal Phase III clinical trial of ACAPODENE(R) (toremifene citrate) in a 20 mg dose for the prevention of prostate cancer in men with high grade PIN.
There are no diagnostic markers for high grade PIN. Currently, high grade PIN can only be diagnosed by prostate needle biopsy. Usually patients undergo a prostate biopsy when they are found to have an elevated serum PSA. About 10% of patients who undergo a prostate biopsy will be found to have high grade PIN. Men with high grade PIN have an approximately 50 percent chance of progressing to prostate cancer within 3 years and an 80% chance within five to seven years. In the United States, 1.1 million men have been diagnosed with high grade PIN, and it has been estimated that there are 14 million men who may unknowingly harbor the condition. There are no medical treatments for high grade PIN.
The Poster is scheduled to be presented Wednesday, April 5, 2006, 8 a.m. - 12 p.m.
-- Identification of ABCA5 as a tissue and urine diagnostic market for Prostatic Intraepithelial Neoplasia (PIN). Abstract Number: 5163; Poster Section: 25; Board 7. About GTx
GTx 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, headquartered in Memphis, Tenn., currently has four clinical programs. 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 PIN. In its third clinical program, GTx 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. In its fourth clinical program, GTx and its partner, Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, are developing andarine, another of GTx’s SARMs, for the treatment of cancer cachexia.
About MacroArray Technologies, LLC
MacroArray Technologies is an early stage biotechnology company formed to capitalize on the growing need for more efficient and effective technology to rapidly identify and develop novel diagnostic markers for the early detection of PIN plus the detection of early stage cancer and other diseases and novel therapeutics linked to the diagnostic markers for a variety of cancers. Core technologies of the company include proteomics platform for novel marker discovery; DNA-protein binding technology; proprietary methods for cloning/identification of genes/proteins; proprietary immunoassays for tissue/fluid markers; linking diagnostic markers to therapeutics; ‘DNA ZYM’ (Ribozyme-like) therapeutic agents for the treatment of cancer; and broad patent application covering discovery process, diagnostics, and therapeutics applications.
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 annual report on form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) 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, Manager, Corporate Communications & FinancialAnalysis, GTx, Inc., +1-901-523-9700
