GTx Initiates Phase IIb Ostarine Clinical Trial For Cancer Cachexia
Tuesday July 3, 7:00 am ET
MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (Nasdaq: GTXI - News), announced today that it has initiated the Phase IIb clinical trial evaluating Ostarine(TM), a selective androgen receptor modulator, or SARM, for the treatment of cancer cachexia.
"We are pleased to initiate the Ostarine Phase IIb cancer cachexia clinical trial on schedule," said Mitchell S. Steiner, MD, Chief Executive Officer of GTx. "Cancer cachexia, as a large unmet medical need, is an important first indication for the late-stage development of Ostarine."
The Phase IIb cancer cachexia clinical trial is a randomized, double blind, placebo controlled study of muscle wasting in 150 patients with non-small cell lung cancer, colorectal cancer, non-Hodgkin's lymphoma, or chronic lymphocytic leukemia. The clinical trial is being conducted at approximately 35 clinical sites in the United States and Argentina. Study participants are being randomized to receive placebo, Ostarine 1 mg, or Ostarine 3 mg for four months. The primary endpoint of the trial is the change in total lean body mass (muscle) at 16 weeks. Secondary endpoints include functional performance and safety.
GTx expects to report top line data in the summer of 2008.
Cachexia is a debilitating, progressive muscle wasting condition manifested by unintentional weight loss, muscle weakness, anemia, fatigue, and death. More than 50% of cancer patients present with or subsequently develop cachexia. Patients with advanced cancer suffering from cachexia may respond poorly to, or not be able to undergo, chemotherapy and radiation therapy. Cancer cachexia is associated with a poor prognosis and can adversely affect a patient's quality of life. There are no drugs approved by the FDA for the treatment of cancer cachexia.
"If Ostarine shows similar increases in lean body mass and improvements in functional performance in the various types of cancer patients in the Phase IIb clinical trial as were observed in the recently completed Phase II proof of concept clinical trial, then Ostarine could become an important therapy for the treatment of cancer cachexia," said Ronald A. Morton, Jr., Chief Medical Officer of GTx.
In 2006, GTx conducted a randomized, double blind, placebo controlled Phase II proof of concept clinical trial of Ostarine in 120 elderly men and postmenopausal women. The top line data revealed a dose dependent increase in total lean body mass in all subjects treated with Ostarine with the 3 mg cohort achieving an increase of 1.4 kg compared to placebo (p less than 0.001) after three months of treatment. Ostarine therapy also resulted in a dose dependent improvement in physical performance measured by a stair climb test with the 3 mg cohort achieving a statistically significant improvement in both speed and power. Ostarine was tissue selective with no apparent change in measurements for serum PSA (prostate), sebum production (skin and hair), or serum LH (pituitary). No serious adverse events were reported in the clinical trial. The most common side effects reported among subjects in both the placebo and Ostarine treatment arms were headache, back pain, and diarrhea.
GTx is also planning to initiate a Phase IIb Ostarine clinical trial for the treatment of chronic kidney disease (CKD) muscle wasting by the end of the year.
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