Helsinn Therapeutics initiates a program clinical pivot global phase III

LUGANO, Switzerland, August 23, 2011/PRNewswire /-

-Helsinn Therapeutics program begins clinical pivot global phase III to evaluate anamorelin in non-small cell lung associated with anorexia/cachexia cancer

Helsinn, a Swiss pharmaceutical companyannounced today that its subsidiary in the United States.UU., Helsinn Therapeutics, has recruited the first patient in the program clinical pivot not advanced (NSCLC) small company in phase III of anamorelin HCl for the treatment of anorexia/cachexia in patients with lung cell cancer.

The clinical program of anamorelin includes two studies pivotal phase III will be held in Dallas, known as Roman-1 and Roman-2. Each one of them is a double-blind, controlled by placebo and multicentre randomized study is expected to recruit a maximum of 477 patients. In addition, patients will have the option to continue the treatment in a study of expansion of 12 weeks referred to as Roman-3.

The criteria for assessment of the primary efficacy of Roman-1 and 2 include a measure of the difference in the change in body mass and muscle strength associated with the weight loss in patients with advanced NSCLC. Pharmacokinetics and additional security measures will be assessed.

Are delighted to start the final testing stage in this important area still devoid of cancer care, ” said the doctor. Riccardo Braglia, CEO of Helsinn Group. Helsinn is committed to helping patients to maintain their strength and energy, while they undergo a treatment for cancer. The development of anamorelin solidifies our commitment for the development of new therapies in palliative care of patients in their fight against cancer. ”

En EE.UU. and in the rest of the world, there are treatments not approved for the cachexia associated with cancer despite the fact that it affects the majority of cancer patients, including up to sixty percent * of the patients with lung cancer , commented Dr. John Friend, senior Vice President of research and development. The first clinical studies suggest that anamorelin can help to solve the significant weight loss and physical function experienced by many patients undergoing treatment for cancer. We hope to be able to confirm this in the clinical program ROMANA. ”

about Anamorelin and Ghrelin

Anamorelin HCl is a receptor agonist ghrelin administered orally and it has been studied previously in approximately 500 subjects, including four phase II trials with 361 patients with cancer. The full results of the studies of phase II is expected to be published in the near future.

Ghrelin is a hormone that occurs mainly in the stomach. To identify the first hormone of the hunger ”, the administration of ghrelin stimulates appetite quickly, which can lead to higher consumption of food and body weight, as well as other physiological activities such as increased body mass and stimulation of gastric emptying.

About cachexia related to cancer

The cachexia is a common but potentially fatal consequence of advanced cancer. The disease causes a decrease in muscle mass, decreased strength and physical function that can begin in the early stages of a patient’s cancer. In addition, it leads to a more committed metabolism, making chemotherapy less tolerable. Up 80 percent of patients with advanced cancer experience cachexia and is the cause of death in 20 to 40% * of these patients. There is no treatment approved for cachexia associated with cancer in the United States or in much of the world.

About Helsinn Group

Helsinn is a privately owned with headquarters in Lugano, Switzerland, pharmaceutical group and subsidiaries operating in Ireland and EE.UU. Helsinn business model is focused on the licensing of pharmaceutical and medical devices in niche therapeutic areas. The Group licensed new chemical entities from the primary stage to the final, complete its development from the results of the chemistry and preclinical/clinical studies, manufacturing and control (CMC), from the development to the registration and maintenance of its approval of market around the world. Helsinn products are out of license to its network of local marketing and trading partners, selected for their in-depth knowledge and know-how of the market, and helped and supported with a wide range of products and scientific management services, including commercial, financial regulatory, legal and medical marketing. Active pharmaceutical ingredients of final dosage forms are manufactured in facilities Helsinn in Switzerland and Ireland cGMP, and distributed worldwide to customers. For more information about Helsinn Group, visit: http://www.helsinn.com.