GTx, FDA agree on Phase III clinical plan for Ostarine for prevention, treatment of muscle wasting in NSCLC.
M2 PHARMA-June 8, 2011-GTx, FDA agree on Phase III clinical plan for Ostarine for prevention, treatment of muscle wasting in NSCLC(C)2011 M2 COMMUNICATIONS
8 June 2011 - US GTx Inc (NASDAQ: GTXI) announced on Monday the clinical trial design for the two Phase III Ostarine registration studies for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer (NSCLC).
The company's announcement follows the conclusion of a series of meetings with the US Food and Drug Administration (FDA), GTx said.
In July, the firm will commence the Ostarine POWER1 and POWER2 (Prevention And Treatment Of Muscle Wasting in CancER) Phase III trials and, assuming enrollment for both studies is completed within one year, expects completion of the two five month studies (last patient last visit) in the fourth quarter of 2012.
In each of the placebo-controlled, double-blind clinical trials, 300 patients with Stage III or IV NSCLC initiating first line chemotherapy will be randomised to placebo or Ostarine 3 mg.
The studies will evaluate as co-primary endpoints the effect of Ostarine on lean body mass assessed by dual x-ray absorptiometry (DXA) and on physical function assessed by the Stair Climb Test (each endpoint ?=0.05) at three months. Durability of effect will be assessed as a secondary endpoint at five months.
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|Date:||Jun 8, 2011|
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