GTX REPORTS DATA ON OSTARINE; WILL PURSUE CANCER CACHEXIA INDICATION

GTx has announced that ostarine, a first-in-class selective androgen receptor modulator, met its primary endpoint in a Phase II, proof-of-concept, double-blind, randomized, placebo-controlled trial in 120 older subjects (60 older men and 60 postmenopausal women). Without a prescribed diet or exercise regimen, all subjects treated with ostarine had a dose-dependent increase in total lean body mass (LBM), with the 3-mg cohort achieving an increase of 1.3 kg compared with baseline and 1.4 kg compared with placebo after three months of treatment.

Treatment with ostarine also resulted in a dose-dependent improvement in functional performance measured by a stair climb test, with the 3-mg cohort achieving a clinically significant improvement in both speed and power. Ostarine continued to demonstrate a favorable safety profile, with no serious adverse events reported.

The trial evaluated four doses of ostarine (0.1, 0.3, 1 and 3 mg) versus placebo. The trial was conducted in five clinical sites in the UK and Germany. In female subjects, ostarine treatment resulted in a dose-dependent increase in LBM with the 3-mg dose having an increase of 1.7 kg compared with baseline and an increase of 1.4 kg compared with placebo. In males, treatment with a 1-mg dose of ostarine resulted in an LBM increase of 0.7 kg compared with baseline and an increase of 1.2 kg compared with placebo, and treatment with a 3-mg dose resulted in an increase of 1.0 kg compared with baseline and an increase of 1.4 kg compared to placebo.

Using this data, GTx has selected cancer cachexia as the initial acute indication for ostarine development. GTx plans to initiate a Phase IIb trial for cancer cachexia by the summer of 2007. GTx also intends to evaluate the ability of ostarine to treat chronic disease indications including end-stage renal disease muscle wasting, frailty and osteoporosis.