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This approval will allow the company to commence clinical trials in patients with histologically confirmed malignancies who present with clinically demonstrable anorexia or anorexia-cachexia syndrome.
Cancer Anorexia-Cachexia Syndrome is a multifactorial syndrome that negatively impacts the functional performance, quality of life and prognosis of cancer patients.
Helsinn Group, the Company focused on building quality cancer care, announces that anamorelin, its investigational novel once-daily ghrelin receptor agonist for the treatment of cancer anorexia-cachexia syndrome (CACS), delivered significant improvements in lean body mass[LBM; one of two primary endpoints] in ROMANA 1, a pivotal 12-week Phase III study in non-small cell lung cancer (NSCLC) patients.
Jennifer Temel, MD, Clinical Director of Thoracic Oncology at Massachusetts General Hospital Cancer Center and a Principal I nvestigator in the ROMANA 1 and ROMANA 2 trials, commented : "These data show that anamorelin represents a new option in the treatment of anorexia-cachexia syndrome in patients with advanced non-small cell lung cancer in which patients frequently experience poor QOL due to symptoms such as cachexia, loss of appetite and fatigue.
Exclusive distribution and licensing agreement signed for the commercialization of Helsinn's compound currently in development for the treatment of cancer anorexia-cachexia syndrome in non-small cell lung cancer (NSCLC) patients