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GTx today announced that following a planned safety review, an independent Data Safety Monitoring Board (DSMB) has recommended that the company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN)
MEMPHIS, TN, USA | July 28, 2008 | GTx, Inc. (Nasdaq: GTXI), today announced that following a planned safety review, an independent Data Safety Monitoring Board (DSMB) has recommended that the company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN). The DSMB meets every six months to review unblinded safety data from the toremifene Phase III clinical trials.
"The DSMB has now reviewed safety data of the nearly 3,000 patients enrolled in the toremifene Phase III clinical trials, with some patients on drug for as long as three years," said Mitchell S. Steiner, MD, Chief Executive Officer of GTx. "We are pleased that the DSMB has recommended we continue this pivotal trial of toremifene 20 mg as planned. We look forward to the results of this important trial, as there remains a large need for therapies that prevent prostate cancer, particularly in patients with high grade PIN who are at high risk for developing the disease."
Nearly 1,600 patients with high grade PIN have been enrolled in the toremifene 20 mg Phase III high grade PIN clinical trial. 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 and Drug Administration. GTx anticipates conducting an efficacy analysis of toremifene 20 mg in the summer of 2009.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions. GTx is developing toremifene citrate, a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: first, a completed pivotal Phase III clinical trial evaluating toremifene 80 mg for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer, and second, an ongoing pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. In 2006, GTx and Ipsen Group entered into a development and collaboration agreement for toremifene citrate in all indications except breast cancer for Europe and the Commonwealth of Independent States (CIS). GTx will file for marketing approval and, if approved, plans to commercialize toremifene 80 mg in the United States. In December 2007, GTx and Merck & Co., Inc. formed a collaboration to discover and develop selective androgen receptor modulators (SARMs), a new class of drugs with the potential to treat sarcopenia, which is the loss of skeletal muscle mass resulting in reduced physical strength and ability to perform activities of daily living, cancer cachexia (muscle wasting), as well as other musculoskeletal conditions. Merck and GTx are conducting several Phase I and Phase II clinical trials evaluating multiple SARM product candidates including Ostarine(TM) (also designated as MK-2866) for sarcopenia. Ostarine is also in a Phase II clinical trial for cancer cachexia which will be completed during the third quarter of 2008. Merck and GTx are evaluating additional muscle loss indications for potential SARM clinical development. GTx also is developing its preclinical compounds, GTx-758, an oral LH inhibitor for advanced prostate cancer, and GTx-878, an estrogen receptor beta agonist for the treatment of benign prostatic hyperplasia and chronic prostatitis.
SOURCE: GTx, Inc. |
