ATLANTA, June 5 /PRNewswire-FirstCall/ -- MacroArray Technologies, LLC, and GTx, Inc., announced that MacroArray Technologies is presenting data from its development of a diagnostic test for prostatic intraepithelial neoplasia (PIN) in a general poster session today at the Annual Meeting of the American Society of Clinical Oncologists (ASCO).
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 is supplying to MacroArray urine and serum samples from patients with high grade PIN enrolled in GTx’s Phase IIb and Phase III clinical trials to assist MacroArray in its development and future 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.
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. Between 8 and 10 percent 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. Currently, there are no approved medical treatments for high grade PIN.
The schedule and meeting place for the session, together with the abstract number, are listed below:
Monday, June 5, 2006 at 8:00 p.m. to 12:00 p.m. - Poster Presentation Session Title: Tumor Biology and Human Genetics Abstract No. 10089; Poster No. U11 “Identification of ABCA5 as a tissue and urine diagnostic marker for Prostatic Intraepithelial Neoplasia or PIN.” Presenter: ME Stearns, Ph.D. Location: Building B, Level 1, Hall B5 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 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.
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 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.
GTx, Inc.
CONTACT: McDavid Stilwell, Manager, Corporate Communications & FinancialAnalysis, GTx, Inc., +1-901-523-9700; or Mark Stearns, President MacroArrayTechnologies, Inc., +1-215-762-1597
