GTx Announces ASCO Presentations Highlighting Effects of Ostarine™ on Physical Function and Survival in Patients with Non-

MEMPHIS, Tenn.--(BUSINESS WIRE)-- GTx announced today in a Phase IIb clinical trial evaluating Ostarine™ (GTx-024), a selective androgen receptor modulator, for the treatment of muscle wasting in patients with cancer, Ostarine™ treatment improved physical function and overcame the negative prognostic effect of severe weight loss on overall survival in patients with non-small cell lung cancer.

These additional study results from GTx’s Phase IIb clinical trial will be presented June 4th and 5th in Chicago at the Annual Meeting of the American Society of Clinical Oncology.

“Non-small cell lung cancer patients with severe muscle loss have poorer treatment outcomes and shorter overall survival,” said Mitchell S. Steiner, MD, CEO of GTx. “This wasting and associated decline in function may have detrimental consequences early in the course of a patient’s malignancy, underscoring the importance of treating this condition at an early stage.”

Abstract # 9022: Effect of GTx-024, a selective androgen receptor modulator (SARM), on physical function in patients with non-small cell lung cancer (NSCLC) with cancer cachexia.
Location: Room S102, Poster Board 6
Time: June 5th, 8 – 12 p.m.
Moderated poster discussion: 11:30 – 12:30 in room S100BC
Lead Author: Steiner, M

In the Phase IIb Ostarine™ clinical trial evaluating 159 cancer patients with either non-small cell lung cancer (NSCLC), colorectal cancer, breast cancer, non-Hodgkin’s lymphoma, or chronic lymphocytic leukemia, physical function was evaluated by the Stair Climb Test as a key secondary endpoint. A subsequent analysis defined clinical benefit as a 10% improvement in stair climb power. Among the 61 patients with NSCLC enrolled in the study, 28 had stair climb power assessed at baseline and again at the conclusion of the study at 16 weeks. Seventy-eight percent (78%) of these patients who were treated with Ostarine™ demonstrated clinical benefit, as compared to 30% of the patients receiving placebo (p=0.02).

Abstract # 9117: The impact of less than 8% weight loss on overall survival in subjects with non-small cell lung cancer (NSCLC) treated in a Phase IIb trial of GTx-024.
Location: Hall A, Poster Board 51D
Time: June 4th, 2 – 6 p.m.
Lead Author: Dodson, S

The Phase IIb Ostarine™ clinical trial enrolled 159 patients with non-small cell lung cancer (NSCLC), colorectal cancer, breast cancer, non-Hodgkin’s lymphoma, or chronic lymphocytic leukemia. Among the entire study population receiving placebo, overall survival was significantly reduced in patients with >8% weight loss at baseline compared to patients with ≤8% weight loss (P=0.003, log rank). In the same analysis of the 61 patients with NSCLC, patients receiving placebo with >8% weight loss at baseline demonstrated a similar survival disadvantage when compared to patients with ≤8% baseline weight loss (P=0.04), with 4 month Kaplan-Meier estimates 100% vs 49% ±14.8%. Ostarine™ treatment overcame the negative prognostic effect of severe baseline weight loss. In both the overall study population and in the NSCLC patient group, there was no difference in overall survival between Ostarine™ treated patients with >8% weight loss at baseline compared to Ostarine™ treated patients with ≤8% weight loss.

About Ostarine™

Ostarine™ is a selective androgen receptor modulator that GTx is developing for the prevention and treatment of muscle wasting, a cancer related symptom. Muscle loss is an independent predictor of performance status, tolerability to cancer treatment, progression free survival and overall survival.

To date, GTx has evaluated Ostarine™ in eight clinical trials involving approximately 600 subjects including three efficacy studies. In the third quarter of 2011, GTx expects to initiate two pivotal Phase III clinical trials evaluating Ostarine™ for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

Full session details for the 2011 Annual Meeting can be found through the ASCO ePlanner:

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 for the treatment of cancer, 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 initiate clinical trials for Ostarine(TM) (GTx-024) and statements related to the therapeutic potential of GTx's 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 will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; (iii) that clinical trials planned to be conducted by GTx may not be initiated or completed on schedule, or at all, or may otherwise be suspended or terminated; (iv) 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 quarterly report on Form 10-Q, filed with the Securities and Exchange Commission on May 9, 2011, 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.


GTx, Inc.
McDavid Stilwell, Director, Corporate Communications

KEYWORDS:   United States  North America  Tennessee

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Hospitals  Medical Devices  Oncology  Radiology  Other Health  Research  Other Science  Nursing  Science  General Health  Managed Care  Physical Therapy



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