Helsinn, a Swiss-based pharmaceutical company, announced that its US subsidiary, Helsinn Therapeutics, has enrolled the first patient in the company’s pivotal phase III clinical programme of anamorelin HCl for the treatment of anorexia/cachexia in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

The anamorelin clinical programme 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, multi-centre 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 US 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 60 per cent 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 programme.”

Anamorelin HCl is an orally administered ghrelin receptor agonist and has been previously studied in approximately 500 subjects, including four completed phase II trials involving 361 patients with cancer. Complete results from phase II studies are expected to be published in the near future.

Ghrelin is a hormone that is predominantly  produced in the stomach. As the first identified “hunger” hormone, administration of ghrelin rapidly stimulates appetite, which may lead to increased food intake and body weight, as well as other physiologic activities including increasing lean body mass and stimulating gastric emptying.

Cachexia is a common yet life-threatening consequence of advanced cancer. The condition causes a decline in lean muscle mass, reduced strength and a decrease in physical function that can begin early in the course of a patient’s cancer. In addition, it results in a compromised metabolism, making chemotherapy less tolerable. Up to 80 per cent of advanced cancer patients experience cachexia and it is the cause of death in 20 to 40 per cent of these patients. There are no approved treatments for cancer-related cachexia in the United States or in much of the world.

Helsinn is a privately owned pharmaceutical group and is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas.