Palonosetron More Effective Than Granisetron In Controlling Nausea According to The Protect Study

New data presented at the ESMO Milan 2010 Congress show a better control of nausea and vomiting with palonosetron versus granisetron in patients undergoing cisplatin or anthracycline plus cyclophosphamide based regimens. Palonosetron superior efficacy is statistically significant in nausea control, following Highly Emetogenic Chemotherapy, in the delayed phase in total study population and also in subgroups by age, female gender and chemotherapy.

Milan, Italy, 11th October 2010 - Palonosetron is effective in preventing CINV (Chemotherapy Induced Nausea and Vomiting) induced by Highly Emetogenic Chemotherapy (HEC) compared to granisetron, according to the data of the PROTECT Study presented by dr. Kaoru Kubota, from the National Cancer Center Hospital Division of Internal Medicine and Thoracic Oncology, Tokyo, Japan, at the ESMO (European Society of Medical Oncology) Milan 2010 Congress. Dr Kubota belongs to the PROTECT Study Group that involved several oncology Centers in Japan as the National Cancer Center Hospital, Tokyo, the Juntendo University School of Medicine, Tokyo, and other Japanese Institutions. Dr. Kubota's presentation, focused on the analysis of the PROTECT study data, showed the higher efficacy of palonosetron in nausea induced by HEC compared to granisetron, in the 1.114 patients study population, and especially in young and female patients, which are the high risk factors for nausea and vomiting. A statistically significant higher percentage of 'nausea free patients' has been shown for the total study population, in the palonosetron plus dexamethasone group versus granisetron plus dexamethasone, during the delayed (24-120 hrs) and overall (0-120 hrs) phases as well as in each day of the delayed phase (daily setting). Furthermore, statistically significant better results have been shown in the analysis by subgroups, for age, gender and chemotherapy. Nausea free rate of palonosetron was similar to that of granisetron in day 1, however it was significantly higher after day 2 both in younger (<55) and older (>=55) patients, in total study patients who received either cisplatin or anthracycline plus cyclophosphamide based study regimens, and in the female patients subgroup.

About Chemotherapy-induced nausea and vomiting (CINV) Chemotherapy-induced nausea and vomiting is among the most dreaded side effects following therapy in patients with cancer. Despite prophylaxis, on the day of chemotherapy, up to 30-45 percent of patients experience nausea or vomiting or require rescue therapy following administration of certain types of emetogenic chemotherapy. The 5-HT3 receptor plays a pivotal role in the process of emesis, and agents that antagonise these receptor subtypes are the basis for control of this effect. Following the development of the first generation 5-HT3 receptor antagonists, such as ondansetron and granisetron, in the late '80s and early '90s, in recent years new compounds have been made available for preventing CINV, including palonosetron.

About Palonosetron Palonosetron (palonosetron hydrochloride) is a second generation 5-HT3 Receptor Antagonist, developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer, with a long half-life of 40 hours and at least 30 times higher receptor binding affinity than currently available compounds. Palonosetron demonstrates, in clinical trials and clinical practice, a unique long-lasting action in the prevention of CINV. The product has shown to be effective in preventing both acute and delayed CINV in patients receiving moderately emetogenic chemotherapy (MEC). A single intravenous dose of palonosetron provides better protection from CINV than first-generation 5-HT3 receptor antagonists throughout a 5-day post-chemotherapy period*. Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions in CINV trials with palonosetron were headache (9 percent) and constipation (5 percent), and they were similar to the comparators. Palonosetron has been developed by the Helsinn Group in Switzerland and today it is marketed as AloxiR, OnicitR, and PaloxiR in more than 50 countries world-wide. Palonosetron, marketed as AloxiR, is the leading brand in the USA within the CINV Day of Chemo segment, and it is steadily growing in the European markets. For more information about palonosetron, please visit the website: www.aloxi.com *This sentence refers to Moderately Emetogenic Chemotherapy (MEC) setting

About the Helsinn Group Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and subsidiaries in Ireland and 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 sold directly through the Group's subsidiaries or 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. Helsinn is the worldwide licensor of palonosetron, a second generation 5-HT3 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer and of post-operative nausea and vomiting (PONV), and of the original nimesulide, a non-steroidal anti-inflammatory drug (NSAID) distributed in more than 50 countries worldwide. Helsinn, with a workforce of around 450 employees in Switzerland, Ireland and USA, reported a 2009 turnover of over CHF 305 million (about EUR 232.0 million at the current conversion exchange rate), covering 85 countries worldwide, with over 20% of this turnover invested in R&D. For more information about Helsinn Group, please visit the website: www.helsinn.com

Contact person: Paolo Ferrari Head of International Marketing HELSINN Healthcare SA Ph: +41 91-985-21-21. info-hhc@helsinn.com
 

Posted: October 2010

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