Helsinn, a Swiss-based pharmaceutical company, announced today that its US subsidiary, Helsinn Therapeutics, has enrolled the first patient in the company's pivotal Phase III clinical program of anamorelin HCl for the treatment of anorexia/cachexia in patients with advanced non-small cell lung cancer (NSCLC).
The anamorelin clinical program includes two pivotal Phase III studies to be run in parallel, named ROMANA-1 and ROMANA-2. Each is a randomized, double-blind, placebo controlled, multicenter global trial that is expected to enroll up to 477 patients. In addition, patients will have the option of continuing treatment in a 12-week safety extension study called ROMANA-3.
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. Pharmacokinetic and additional safety measures will also be evaluated.
"We're very pleased to begin the final stages of testing in this important yet underserved area of cancer care," commented Dr. Riccardo Braglia, Chief Executive Officer of Helsinn Group. "Helsinn is committed to helping patients maintain their strength and energy while they undergo cancer treatment. The development of anamorelin solidifies our commitment to developing new supportive care therapies for patients in their fight against cancer."
"In the U.S. and much of the rest of the world, there are no approved treatments for cancer-related cachexia even though it affects a majority of cancer patients, including up to sixty percent of those with lung cancer," commented Dr. John Friend, Senior Vice President, Research and Development. "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."
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