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news.Helsinn Therapeutics has recruited first patient in a double-blind, multicenter, randomized, placebo controlled, global Phase III clinical program evaluating anamorelin HCl as a treatment of anorexia/cachexia in patients with advanced non-small cell lung cancer (NSCLC).
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The anamorelin clinical program consists of two pivotal Phase III studies to be run in parallel – Romana-1 and Romana-2.
The company expects to recruit around 477 patients in each trial.
The primary efficacy endpoints of Romana-1 and 2 include a measure of difference in the change in lean body mass and muscle strength in patients with advanced NSCLC-associated weight loss.
Helsinn R&D senior vice president John Friend said earlier clinical studies suggest anamorelin may help address the significant loss of weight and physical function experienced by many patients undergoing treatment for cancer.
"We look forward to confirming this in the Romana clinical program," Friend said.