GTx, Inc. To Continue With Pivotal Studies Of Acapodene
MEMPHIS, Tenn., Jan. 19 /PRNewswire-FirstCall/ -- GTx, Inc. (Nasdaq: GTXI - News), the Men's Health Biotech Company, today announced that a per protocol interim safety review by an independent Drug Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III 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. GTx is evaluating the use of ACAPODENE in an 80mg dose for the treatment of multiple side effects of androgen deprivation therapy (ADT) in men with advanced prostate cancer, and of ACAPODENE 20mg dose for the prevention of prostate cancer in high risk men.
In the first study, 1,388 prostate cancer patients on ADT at approximately 150 clinical centers in the United States and Mexico were randomized to receive daily an oral, 80mg dose of ACAPODENE or placebo. The primary endpoint of the trial is a reduction in vertebral fractures. Secondary endpoints include improvements in bone mineral density (BMD), lipid profile, gynecomastia, and hot flashes. The two-year trial is being conducted under a Special Protocol Assessment (SPA) with the United States Food & Drug Administration (FDA). In the second half of 2005, GTx completed enrollment of the trial and conducted an interim analysis of BMD in the first 200 patients to finish one year of treatment. The interim analysis was highly statistically significant with ACAPODENE 80mg therapy resulting in BMD increases versus placebo of +2.3% in the lumbar spine (p<0.001), +2.0% in the hip (p=0.001), and +1.5% in the femur (p=0.009).
In the second study, ACAPODENE 20mg is being evaluated under a SPA with the FDA for the prevention of prostate cancer in men with the premalignant lesion called high grade prostatic intraepithelial neoplasia (PIN). 1,260 men are being randomized at more than 130 sites in the United States, Canada, Mexico and Argentina to receive daily an oral, 20mg dose of ACAPODENE or placebo. The primary endpoint of the trial is the reduction of prostate cancer incidence. Enrollment of the trial is expected to be completed in the first quarter of 2006.
"The DSMB reviewed safety data of more than 2,000 patients enrolled in our two Phase III trials and recommended that GTx continue with the trials as planned. This welcome news, along with the efficacy demonstrated recently in the interim analysis of BMD in our ADT trial, reduces the risk in ACAPODENE's clinical development and improves the prospects that we will be able to submit these product candidates for marketing approval," said Mitchell Steiner, MD, Chief Executive Officer of GTx.
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.
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.
Source: GTx, Inc.