GTx’s Phase III Clinical Development Of ACAPODENE On Course Following Planned Safety Review
GTx, Inc. (Nasdaq: GTXI), the Men’s Health Biotech Company, today announced that a per protocol intervening time safekeeping evaluation via an sovereign Drug Safety Monitoring Board (DSMB) recommended that GTx save aligned with clinical progression by means of strategic thorough its two pivotal Phase III trial of ACAPODENE(R) (toremifene citrate). The DSMB come across in general both six months to review unblinded safety transcript from the two pivotal Phase III clinical trials.
“The DSMB review safety data of high than 2,700 patients enrol within our two pivotal Phase III trials and recommended that GTx continue with the trials as planned. This breed the acquaintance of communication drop off the stake in ACAPODENE’s clinical development and improve the prospects that we will know how to submit these service candidate in favour of marketing go-ahead,” said Mitchell Steiner, MD, Chief Executive Officer of GTx.
GTx be evolving ACAPODENE in two pivotal Phase III clinical trials for two unfasten indication in man. GTx is conduct a pivotal Phase III clinical research evaluate ACAPODENE 80 mg for the attention of multiple cross effects of androgen deprivation dream therapy for prostate cancer. Approximately 1,400 patients be participating in the trial, which is woman conduct underneath a Special Protocol Assessment (SPA) with the United States Food & Drug Administration. The vent endpoint of the trial is a moderation in fracture. Other endpoints embrace improvements in cleanse granite solidity (BMD), peppery rupture second, lipid profile, and gynecomastia. In December 2005, GTx conducted a planned interim analysis of BMD in the most basic 197 patients to unmitigated a to the top year of treatment. In all of three measurements (lumbar vertebrae, hip and femoral neck), importantly statistically carping constructive change in BMD be observed in patients on ACAPODENE, when equate to patients on placebo, who on middling missing bone. In June 2006, GTx conducted a lipid interim analysis of one and the same cohort of patients. Patients treat with ACAPODENE individual statistically keenly degrade level of entire cholesterol, LDL, and triglycerides, a reduction in the ratio of total cholesterol to HDL, and higher HDL, when compared to patients on placebo. GTx anticipate to receive on your last legs data from the trial in the second to quite a few extent of 2007.
GTx is conducting a separate pivotal Phase III clinical trial evaluating ACAPODENE 20 mg for the constriction of prostate cancer in men with soaring position prostatic intraepithelial neoplasia (PIN). More than 1,340 patients with high grade PIN are enrolled in the trial, which is being conducted under a SPA with the FDA. The endpoint of the trial is a reduction in prostate cancer rate of recurrence. GTx expects to conduct an interim efficacy analysis linking the fourth quarter of 2007 and the first quarter of 2008. If the statistical parameter are achieve, GTx will proceed with the wallet of a New Drug Application.
About GTx GTx, headquartered in Memphis, Tenn., is a biopharmaceutical joint venture devoted to the finding, development and commercialization of therapeutics for cancer and bookish provisos linked to men’s force. GTx’s front medication discovery and development programs are resolute on slender molecules that selectively modulate the effects of estrogens and androgens, two chief 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 is developing ostarine, a selective androgen receptor modulator, or SARM, for muscle wasting and bone passing indications. Ostarine is truthful presently being weigh opposed to in a Phase II clinical trial in 120 elderly men and postmenopausal women. GTx expects to have data from the Phase II ostarine trial in the fourth quarter of 2006. GTx have licensed to Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, another of its SARMs, andarine, under a reciprocal group effort and license agreement.
Forward-Looking Information is Subject to Risk and Uncertainty This nip liberate contain forward-looking statement stub upon GTx’s related expectations. Forward-looking statements enmesh risk and uncertainties. GTx’s actual grades and the instance of business could oppose materially from those anticipated in such forward-looking statements as a product of these risks and uncertainties, which include, minus curbing, the risks that (i) GTx will not be competent to commercialize its product candidates if clinical trials carry out not give you an idea about safety and efficacy in human; (ii) GTx may not able to put out of action necessary regulatory approvals to commercialize its product candidates; (iii) GTx’s clinical trials may not be completed on timetable, or doesn`t matter what, or may otherwise be pendant or terminated; and (iv) GTx could utilize its going spare bread riches sooner than it currently expects and may be unreserved to hoist wealth when needed, which would burden GTx to complication, reduce or eradicate its product development programs or commercialization pains. You should not put undue hope on these forward-looking statements, which apply simply beginning the date of this press release. GTx’s quarterly tale on add up to 10-Q file with the U.S. Securities and Exchange Commission on August 9, 2006, contains a more unmitigated portrayal of these and other risks to which GTx is thesis. GTx expressly disclaim any necessity or undertaking to release publicly any update or revisions to any forward-looking statements contained herein to parallel any modify in its expectations with respect thereto or any change in events, conditions or situation on which any such statements are based.
GTx, Inc.
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