MEMPHIS, Tenn., Jan. 31 /PRNewswire-FirstCall/ -- GTx, Inc. , the Men’s Health Biotech Company, today announced that it has entered into an exploratory collaboration with Gen-Probe, Incorporated to evaluate the ability of Gen-Probe’s research-stage PCA3 assay to detect high grade prostatic intraepithelial neoplasia, or PIN.
High grade PIN is the precancerous lesion of the prostate. Clinical studies have shown that men with high grade PIN are at high risk for prostate cancer. Today high grade PIN can only be diagnosed by prostate biopsy. There are 1.1 million men in the U.S. with biopsy confirmed high grade PIN, with 115,000 new cases diagnosed each year. Yet, it is estimated that that there are 15 million men in the U.S. who unknowingly harbor the condition. The ability to identify high grade PIN through a non-invasive diagnostic test may allow more patients to find out whether they are at high risk for prostate cancer.
Under terms of the agreement, GTx will provide Gen-Probe with urine samples from patients enrolled in GTx’s clinical trials testing ACAPODENE(R) (toremifene citrate 20mg) for the prevention of prostate cancer in men with high grade PIN: a completed Phase IIb trial of 514 patients and an ongoing large pivotal Phase III trial in 1,260 men with high grade PIN at more than 130 sites in the United States, Canada, Mexico and Argentina. Gen-Probe will evaluate the samples from this special patient cohort with its research-stage test for PCA3 gene expression. PCA3 has been shown to be highly over-expressed in malignant prostate cells. Its pattern of expression may help identify a high grade PIN subpopulation.
“A non-invasive, urine based test for high grade PIN would facilitate the diagnosis of men who are at high risk for developing prostate cancer,” said GTx Chief Executive Officer, Mitchell Steiner, MD. “We are delighted to expand our collaborations in this area to work with Gen-Probe to test the PCA3 Assay as a potential test for high grade PIN.”
“This agreement provides us access to high-quality clinical specimens that may help further establish the performance characteristics of our investigational PCA3 assay, including whether it has utility in detecting high-grade PIN and discriminating this condition from prostate cancer,” said Harry Rittenhouse, PhD, Gen-Probe’s senior director for cancer research.
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 (toremifene citrate), a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: (1) a pivotal Phase III clinical trial for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer and (2) 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 for the treatment of wasting associated with burns. GTx is also evaluating clinical development of ostarine for the treatment of other muscle wasting conditions. In its fourth clinical program, GTx and its collaborating 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. GTx is working with Ortho Biotech to plan a Phase II clinical trial of andarine.
About Gen-Probe
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe markets a broad portfolio of products that use the Company’s patented technologies to detect infectious microorganisms, including those causing sexually transmitted diseases, tuberculosis, strep throat, pneumonia and fungal infections. The Company also developed and manufactures the only FDA-approved blood screening assay for the simultaneous detection of HIV-1 and HCV, which is marketed by Chiron Corporation. In addition, Gen-Probe’s TIGRIS instrument is the only fully automated, high-throughput NAT system for diagnostics and blood screening. Gen-Probe has more than 20 years of NAT expertise, and its products are used daily in clinical laboratories and blood collection centers worldwide. The Company received the 2004 National Medal of Technology, America’s highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 900 people. For more information, go to http://www.gen-probe.com.
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 prospectus supplement filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to Rule 424(b)(5) on October 12, 2005, 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.
GTx, Inc.
CONTACT: McDavid Stilwell, Manager, Corporate Communications & FinancialAnalysis of GTx, Inc., +1-901-523-9700
Web site: http://www.gen-probe.com/
