Helsinn Enrols First Patient in Phase III Cancer Drug Trial
The primary efficacy endpoints include a measure of difference in the change in lean body mass and muscle strength in patients with weight loss associated with non-small cell lung cancer.
Swiss-based pharmaceutical company Helsinn Therapeutics has enrolled its first patient in a Phase III clinical programme evaluating Anamorelin HCl as a treatment of anorexia and cachexia in patients with advanced non-small cell lung cancer.
The two randomised, double-blind, placebo controlled, multicentre and global Phase III studies – Romana-1 and Romana-2 – are expected to enrol up to 477 patients each. The primary efficacy endpoints include a measure of difference in the change in lean body mass and muscle strength in patients with weight loss associated with non-small cell lung cancer.
Pharmacokinetic and additional safety measures will also be evaluated in the trials.
Anamorelin HCl is an orally ad
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