In early December 2006, GTx/NASDAQ: GTXI said its ostarine treatment met its primary and secondary endpoints in a mid-stage trial. The study was conducted on 120 elderly men and women in the U.K. and Germany. Patients treated with ostarine measured against a placebo showed both significant muscle growth and functional performance. Ostarine, a first-in-class drug, is a selective androgen receptor modulator, or SARM with a long half-life (24 hours) that provides levels of circulating androgens unattainable with anabolic steroidal agents and is being developed for the treatment of a variety of medical conditions relating to muscle wasting and bone loss, including osteoporosis, andropause (the male version of menopause), cachexia (muscle wasting) related to cancer, end-stage renal disease, HIV/AIDS, and burns, and for treatment of sarcopenia during rehabilitation while patients recover from extended hospitalizations from trauma, burns, and surgery. Ostarine is designed to elicit anabolic activity without unwanted androgenic side effects on prostate and skin sebaceous glands.In preclinical trials, ostarine distinguished itself from current osteoporosis drugs which only treat bone loss by also increasing muscle. The use of similar drugs has been limited over concerns of side-effects, but according to GTx, ostarine use resulted in no seriously adverse effects.
As a result of the positive mid-stage study, the company has selected cancer cachexia as the initial acute indication for ostarine development to begin in the first half of 2007, with an additional mid-stage trial for cachexia treatment scheduled for the summer of 2007. The data from the completed Phase II study will provide GTx and the FDA with information that will help define the regulatory requirements for a larger scale Phase IIb study and/or Phase III program. Cachexia is one of the most devastating symptoms of cancer, often occurring in patients with lung, GI and pancreatic cancer, and is highly correlated with death. There are over 1.3 million patients diagnosed with cancer each year in the U.S. and cachexia affects nearly a third of newly-diagnosed cancer patients. Currently, there are no drugs approved by the FDA for the treatment of the cachexia.
GTx also intends to evaluate the ability of ostarine to treat chronic disease indications, including end-stage renal disease, muscle wasting, frailty and osteoporosis.
The next catalyst for GTx is the release of Phase III Acapodene data in men with prostate cancer on androgen deprivation therapy in the fourth quarter of 2007. Acapodene is being tested as a treatment for multiple serious side-effects of androgen deprivation therapy.
With anticipated news flow, we believe GTx shares will continue its upward momentum. Thus, we maintain our buy rating and 12-month price target of $22.
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