Shares of GTXI/NASDAQ: GTXI have pulled back, due to investors’ worry over the design of the Phase III study evaluating Acapodene as a treatment for side effects associated with androgen deprivation therapy (ADT) in advanced prostate cancer. The primary concern is that the trial is statistically underpowered. Patients enrolled in the study were assigned randomly on a one-to-one ratio to receive orally either 80 mg Acapodene or placebo. The primary endpoint of the trial is reduction in vertebral fractures. The trial was designed to enroll approximately 1200 patients to demonstrate a 40% reduction in vertebral fractures with 80% power to achieve a p-value of 0.05. A 40% reduction is considered very conservative. Secondary endpoints include changes in bone mass density of the hip and spine. The trial has enrolled 1392 men with prostate cancer who have been treated with ADT for at least 6 months and are at increased risk of fracture based on either being older than 70 years of age or having evidence of osteopenia by baseline dual energy x-ray absorptiometry scan. There has been recent speculation that the event rate in the study was at jeopardy due to the co-mingling of data with healthy subjects who are at low risk of fracture.
Until the data is in, no one knows what the exact event rate to measure fracture is, but we see the dip as an opportunity to buy shares of GTXI. The Phase III study is projected to be complete in late 2007. Allowing time for lockdown of the trial’s database, data queries, and follow-up visits, top-line data may be available by the end of 2007 or in the first quarter of 2008.
Meanwhile, GTXI will take steps to advance its novel, oral selective androgen receptor modulator, Ostarine, into two Phase IIb studies. By June, a study evaluating Ostarine in patients with non-small cell lung cancer who are suffering from cancer cachexia will commence, and by the end of 2007, a second study in patients suffering from muscle wasting due to chronic kidney disease is expected to initiate.
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