Healthcare Industry News: Acapodene
News Release - February 2, 2007
GTx's Phase III Clinical Development of ACAPODENE on Course Following Planned Safety ReviewMEMPHIS, Tenn.--(HSMN NewsFeed)--GTx, Inc. (NASDAQ:GTXI ), the Men's Health Biotech Company, today announced that a per protocol interim safety review by an independent Data Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III clinical trials of Acapodene® (toremifene citrate). The DSMB meets regularly every six months to review unblinded safety data from the two pivotal Phase III clinical trials.
"The DSMB reviewed safety data of the approximately 2,900 patients enrolled in our two pivotal Phase III trials and recommended that GTx continue with the trials as planned under the existing protocols," said Mitchell S. Steiner, MD, Chief Executive Officer of GTx. "This welcome news reduces the risk in Acapodene's clinical development. There are more than 350,000 patient years of experience with toremifene 60 mg, which has already been approved for the treatment of advanced breast cancer. The extensive safety database from these two large clinical trials using Acapodene 20 mg and Acapodene 80 mg will be a critical component of the applications for marketing approval, the first of which we anticipate submitting in 2008."
GTx is developing Acapodene in two pivotal Phase III clinical trials for two separate indications in men. GTx is conducting a pivotal Phase III clinical trial evaluating Acapodene 80 mg for the treatment of multiple side effects of androgen deprivation therapy for prostate cancer. Approximately 1,400 patients have been enrolled in the trial, which is being conducted under a Special Protocol Assessment (SPA) with the United States Food & Drug Administration. The primary endpoint of the trial is a reduction in fractures. Other endpoints include improvements in bone mineral density (BMD), hot flashes, lipid profiles, and gynecomastia. In December 2005, GTx conducted a planned interim analysis of BMD in the first 197 patients to complete a full year of treatment. In each of three measurements (lumbar spine, hip and femoral neck), highly statistically significant positive changes in BMD were observed in patients on Acapodene, when compared to patients on placebo, who on average lost bone. In June 2006, GTx conducted a lipid interim analysis of the same cohort of patients. Patients treated with Acapodene had statistically significantly lower levels of total cholesterol, LDL, and triglycerides, as well as a reduction in the ratio of total cholesterol to HDL, when compared to patients on placebo. GTx expects to receive final data from the trial in the fourth quarter of 2007.
GTx is conducting a separate pivotal Phase III clinical trial evaluating Acapodene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN). Nearly 1,500 patients with high grade PIN have been 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 incidence. GTx expects to conduct an interim efficacy analysis between the fourth quarter of 2007 and the first quarter of 2008. If the statistical parameters are achieved, GTx will proceed with the filing of a New Drug Application.
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. GTx is developing Acapodene® (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 has licensed to Ipsen Limited exclusive rights in Europe to develop and commercialize Acapodene®. GTx also is developing ostarine, a first-in-class selective androgen receptor modulator, or SARM. GTx plans to initiate a Phase IIb ostarine clinical trial for cancer cachexia by the summer of 2007. GTx believes that ostarine also has the potential to treat a variety of other indications associated with muscle wasting and bone loss, including end stage renal disease muscle wasting, frailty and osteoporosis.
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 December 13, 2006, 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.
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