GTx Announces Upcoming ASCO Presentations of Additional Study Results from Clinical Trials Evaluating Ostarine[TM] for Cancer Cachexia and Toremifene 80 mg for the Reduction of Fractures in Men with Prostate Cancer on ADT.
Ostarine (GTx-024) is a first in class selective androgen receptor modulator, or SARM, which GTx is evaluating for the treatment of cancer cachexia (muscle loss). To date GTx has evaluated Ostarine in 7 clinical trials with more than 580 patients, including a Phase IIb clinical trial in 159 patients with cancer cachexia.
* "Effect of GTx-024, a selective androgen receptor modulator (SARM), on stair climb performance and quality of life (QOL) in patients with cancer cachexia."
Lead Author: Steiner M
Abstract# 9147 (June 7, 1 - 5 p.m., S Hall A2)
Toremifene 80 mg is a selective estrogen receptor modulator, or SERM, which GTx is evaluating for the reduction of fractures and treatment of other estrogen deficiency side effects of androgen deprivation therapy for prostate cancer. GTx expects to initiate the pivotal Phase III TREAT 2 (Toremifene for Reduction of fractures and other Estrogen deficiency side effects in men on Androgen deprivation Therapy) clinical trial by year end 2010.
* "Effect of toremifene on fracture risk in men younger than age 80 on androgen deprivation therapy."
Lead Author: Brawer M
Abstract# 4676 (June 7, 1 - 5 p.m., S Hall A2)
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 for the treatment and prevention of cancer, the treatment of side effects of anticancer therapy, cancer supportive care, and other serious medical conditions.
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 include, but are not limited to, statements relating to GTx's plans to continue to pursue the development of and marketing approval for, and the potential commercialization of, toremifene 80 mg, and the continued development and potential commercialization of GTx's other product candidates. 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 (i) that GTx and its collaboration partner will not be able to commercialize their product candidates if clinical trials do not demonstrate safety and efficacy in humans, including in any additional clinical trials that GTx may conduct for toremifene 80 mg to reduce fractures in men with prostate cancer on ADT; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates, including toremifene 80 mg to reduce fractures in men with prostate cancer on ADT or toremifene 20 mg for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, in a timely manner or at all; (iii) that clinical trials being conducted or planned to be conducted by GTx and its collaboration partner may not be initiated or completed on schedule, or at all, or may otherwise be suspended or terminated; (iv) related to GTx's dependence on its collaboration partner for product candidate development and commercialization efforts; (v) related to GTx's reliance on third parties to manufacture its product candidates and to conduct its clinical trials; and (vi) that 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 candidate 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 annual report on Form 10-Q filed with the SEC on May 4, 2010 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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|Comment:||GTx Announces Upcoming ASCO Presentations of Additional Study Results from Clinical Trials Evaluating Ostarine[TM] for Cancer Cachexia and Toremifene 80 mg for the Reduction of Fractures in Men with Prostate Cancer on ADT.|
|Article Type:||Clinical report|
|Date:||May 20, 2010|
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