Palonosetron Warrants Adequate Caloric Intake In Oncology Patients Receiving High Emetogenic Chemotherapy

A new, innovative study shows that a single dose of palonosetron, the second generation 5-HT3 antagonist, plus dexamethasone not only prevents chemotherapy-induced nausea and vomiting (CINV), but also allows adequate caloric intake in oncology patients. Data presented today at the ESMO Symposium on Cancer and Nutrition in Zurich, Switzerland

Zurich, Switzerland, March 20, 2009 - New data presented today at the ESMO (European Society of Medical Oncology) Symposium on Cancer and Nutrition in Zurich shows that palonosetron, a second generation 5-HT3 receptor antagonist, warrants adequate caloric intake in oncology patients receiving high emetogenic chemotherapy (HEC).

The result comes from an innovative study conducted in the Oncology Institute of Ospedale V. Fazzi of Lecce, Italy, by the research team of Dr. Vito Lorusso. The findings confirmed the efficacy of a single dose of palonosetron and dexamethasone to control chemotherapy-induced nausea and vomiting (CINV) episodes in patients treated with HEC (cisplatin and/or epirubicin and/or iphosphamide) for soft tissue sarcoma: 76 percent of the patients achieved complete response (no vomiting, no use of rescue medication), 74 percent complete control (complete response and no more than mild nausea), in the 7-day period following chemotherapy, after palonosetron treatment. Moreover, the results demonstrated that patients with no vomiting and without nausea had a median daily food intake of 1500 Kcal and 1600 Kcal in the acute and delayed period respectively, which is an adequate caloric consumption. "Palonosetron not only confirms its ability to control nausea - Dr. Lorusso commented - but considering the relevance of a correct nutritional status for cancer patients, it also demonstrates to allow an adequate caloric consumption, in the 7 day period following chemotherapy. Moreover this benefit prolonged over the monitored period, allowing patients to avoid chemotherapy related weight loss." "These results are of special interest in light of ensuring an even more effective supportive care to patients undergoing high emetogenic chemotherapy. From this point of view, such an outcome is consistent with Helsinn's commitment in this particular setting" stated Prof. Mauro Bianchi, Medical Development Director at Helsinn.

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 (AloxiR, OnicitR, PaloxiR) Palonosetron (palonosetron hydrochloride) is a selective 5-HT3 receptor antagonist, developed for the prevention of 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 is a second generation 5-HT3 receptor antagonist, and demonstrates, in clinical trials and clinical practice, a unique long-lasting action in the prevention of CINV. Since its availability in USA in September 2003, and since then in more than 40 countries world-wide, there have been over 10 million administrations of palonosetron. The product has shown to be effective in preventing both acute and delayed CINV in patients receiving moderately emetogenic chemotherapies. A single intravenous dose of palonosetron (0.25 mg) provides better protection from CINV than first-generation 5-HT3 receptor antagonists throughout a 5-day post-chemotherapy period*. This means that a single administration of palonosetron also grants protection during the delayed phase of CINV*. Palonosetron 0.075 mg IV is also approved by FDA as a single intravenous dose administered immediately before the induction of anaesthesia for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions (incidence ?2 percent) in CINV trials with palonosetron were headache (9 percent) and constipation (5 percent), and they were similar to the comparators. In PONV trials, the most commonly reported adverse reactions were QT prolongation (5 percent), bradycardia (4 percent), headache (3 percent), and constipation (2 percent), similar to placebo.

Palonosetron has been developed by Helsinn Healthcare SA of Switzerland and today it is marketed as AloxiR, OnicitR, and PaloxiR. 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. Its approval in Japan is expected during 2009. For more information about palonosetron, please visit the website: www.aloxi.com.

About Helsinn Group Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and subsidiaries in Ireland and USA. Helsinn is the worldwide licensor of palonosetron. Helsinn's unique business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early 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 subsidiaries, or eventually 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.

*These sentences refer to Moderately Emetogenic Chemotherapy (MEC) setting

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

 

 

 

Posted: March 2009

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