Among men in the intent-to-treat population with a detectable PSA (PSA ?‰? 1 ng/ml) at baseline (n=419), significantly fewer men treated with toremifene 80 mg had PSA progression over time compared to men taking placebo (27% versus 37%, respectively; p < 0.05). This subgroup analysis is consistent with the recommendations of the Prostate Cancer Clinical Trials Working Group to measure prostate cancer progression in clinical studies. In another analysis among men with an undetectable PSA (PSA < 1 ng/ml) at baseline (n= 698), there was no difference in PSA progression in men treated with toremifene 80 mg compared to men taking placebo.
"These new safety data are consistent with the mechanism of action observed in other studies evaluating toremifene, which have demonstrated inhibition of prostate growth in animal models, as well as in our Phase IIb clinical trial evaluating toremifene for the prevention of prostate cancer," said Mitchell S. Steiner, MD, Chief Executive Officer of GTx.
"In men with advanced prostate cancer, PSA is a sensitive marker of progression and is followed closely by physicians and patients to monitor the underlying cancer," Dr. Steiner continued. "It is encouraging to find that in our Phase III clinical trial in men with advanced prostate cancer on ADT, who have castrate levels of testosterone and estrogen, toremifene 80 mg treatment resulted in fewer men with detectable PSA at baseline demonstrating PSA progression over time when compared to placebo."
Additional data from the study were also highlighted during the presentation. An efficacy analysis studied changes in three serum markers of bone turnover: C-telopeptides, bone specific alkaline phosphatase (bALP), and osteocalcin. Changes in the three markers were further evaluated among men in the trial who experienced a new morphometric vertebral fracture. The analysis of these data show:
- Increases in C-telopeptides serum levels were associated with a significantly greater risk for the development of a new morphometric vertebral fracture (p < 0.01).
- Increases in bALP serum levels were associated with risk for new morphometric vertebral fracture (p < 0.01).
- Changes in osteocalcin serum levels were similar to those observed for other serum markers, but did not reach statistical significance.
About the toremifene 80 mg Phase III ADT clinical trial
The two year double-blind, placebo-controlled, randomized study of 1,389 ADT patients, was conducted at approximately 150 clinical sites in the United States and Mexico. The primary endpoint was new morphometric vertebral fractures. Other key secondary endpoints included bone mineral density, lipid changes, hot flashes, and gynecomastia.
Safety
Toremifene 80 mg was well tolerated. Among the most common adverse events that occurred in over 2% of study subjects were joint pain (treated 7.3%, placebo 11.8%), dizziness (treated 6.3%, placebo 5.0%), back pain (treated 5.9%, placebo 5.2%), and extremity pain (treated 5.0%, placebo 4.4%). Venous thromboembolic events (VTE), which included both deep venous thrombosis and pulmonary embolism, were 2.4% in the toremifene 80 mg treated group and 1.02% in the placebo group. The majority of VTEs occurred in men at high risk for a VTE including: age greater than 80 years, history of VTE, recent surgical procedure and immobilization. Excluding high risk patients over the age of 80 years and with a history of VTEs, the VTEs were 1.3% in the toremifene 80 mg treated group and 1.0% in the placebo group (p=0.38). There was no difference in strokes, myocardial infarctions, or deaths between the two groups.
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 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 in 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. gtxinc
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 and its collaboration partners will not be able to commercialize their 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 product candidates; (iii) clinical trials being conducted by GTx and its collaboration partners 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 it 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 quarterly report on Form 10-Q filed August 5, 2008 contain 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.
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