Helsinn Initiates Extension Study in Late-Stage Anamorelin Clinical Program for Non-Small Cell Lung Cancer-Associated Anorexia/Cachexia

By Helsinn Group, PRNE
Tuesday, December 6, 2011

LUGANO, Switzerland, December 7, 2011 -

Helsinn, a Swiss-based pharmaceutical company, announced today that its US subsidiary, Helsinn Therapeutics Inc., has enrolled the first patient in ROMANA-3, the Company’s 12-week safety extension study.

The ROMANA-3 safety extension study is recruiting patients who have successfully completed ROMANA 1 or ROMANA 2, the Company’s two phase III studies running in parallel that are evaluating anamorelin HCI for the treatment of anorexia/cachexia in patients with advanced non-small cell lung cancer (NSCLC).  The two studies will enroll approximately 477 patients each in 15 countries, with sites in North America, Europe, Russia, Australia and the Middle East.  Patients who complete ROMANA 1 or 2 have the option of continuing treatment in the ROMANA 3 safety extension study.

“We are pleased with our progress since launching the anamorelin phase III clinical program this past August.  The fact that patients have already opted-in to our extension study underscores the urgent need for new and effective supportive care treatments that address cancer cachexia”, said Dr. John Friend, Senior Vice President, Research and Development, Helsinn Therapeutics.

“Cancer-related cachexia has a much greater impact on both quality of life, and survival, than many clinicians recognize,” said Dr. Renato LaRocca, Director of the Kentuckiana Cancer Institute in Louisville, Kentucky and a principal investigator in the ROMANA clinical program. “Helping patients maintain or increase total weight can have a significant impact on their ability to tolerate treatment, and quality of life.”

There is currently no approved treatment for cancer-related cachexia in the United States and much of the rest of the world though it affects a majority of cancer patients, including up to sixty percent* of those with lung cancer.  The ROMANA clinical studies are intended to measure the change in lean body mass and muscle strength in patients with advanced NSCLC-associated weight loss.  The Company expects to complete enrollment in ROMANA-1 and ROMANA-2 in the second half of 2013, with results being reported in early 2015.

“Helsinn is proud of this important milestone in anamorelin’s phase III clinical program, which emphasizes Helsinn’s commitment in developing a treatment for cancer-related cachexia, still an underserved area of cancer care worldwide. The concept and design of the ROMANA clinical program will be explained by Dr. John Friend during a session entitled Update on Anabolics and Related Therapies at the 6th Cachexia Conference in Milan, on December 9th,” said Dr. Riccardo Braglia, Chief Executive Officer, Helsinn Group.

About Anamorelin and Ghrelin

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.

About Cancer-related Cachexia

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 percent of advanced cancer patients experience cachexia and it is the cause of death in 20 to 40 percent* of these patients. There are no approved treatments for cancer-related cachexia in the United States or in much of the world.

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland and the USA. Helsinn’s business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early to late stage new chemical entities, completes their development from the performance of pre-clinical/clinical studies and Chemistry, Manufacturing and Control (CMC), development to the filing for and attainment of their market approval worldwide. Helsinn’s products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how, and assisted and supported with a full range of product and scientific management services, including commercial, regulatory, financial, legal and medical marketing advice. The active pharmaceutical ingredients and the finished dosage forms are manufactured at Helsinn’s cGMP facilities in Switzerland and Ireland, and supplied worldwide to its customers. For more information about Helsinn Group, please visit the website: www.helsinn.com.

*National Cancer Institute


Paola Bonvicini, Head of Communication & Press Office, Helsinn Healthcare SA, +41-91-985-21-21, info-hhc at helsinn.com

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