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Palonosetron effectively prevents emesis and nausea induced by high dose chemotherapy in patients undergoing autologous stem cell transplantation

Lugano/Berlin, Germany (ots)

Single dose palonosetron achieves
optimal control of acute emesis in patients receiving multiday-high 
dose chemotherapy before autologous stem cell transplantation. The 
addition of a second dose of palonosetron after 48 hours 
significantly reduces the detrimental impact of nausea on daily 
activities in this setting. Data presented at the ECCO-ESMO joint 
European oncology conference in Berlin, Germany
New data presented today at the ECCO-ESMO joint European oncology 
conference in Berlin show that palonosetron, a second generation 
5-HT3 receptor antagonist, importantly improves emesis and nausea 
control in patients undergoing multiday-high dose chemotherapy (HDT) 
and autologous stem cell transplantation (ASCT). Moreover the 
addition of a second palonosetron dose 48 hours after the first one 
significantly reduces the detrimental impact of nausea on daily 
activities.
The result comes from a spontaneous study conducted by the team 
coordinated by Dr. Antonio Pinto at Hematology Oncology and Stem Cell
Transplantation Unit, National Cancer Institute - IRCCS Fondazione 
"Sen. G. Pascale", Naples, Italy. "The vast majority of patients 
undergoing multiday-high dose chemotherapy and autologous stem cell 
transplantation still experience major acute and delayed 
chemotherapy-induced nausea and vomiting (CINV), showing how emesis 
control in the ASCT setting remains sub-optimal", said Dr. Pinto. 
"Moreover, we know that palonosetron is effective in preventing CINV 
in patients receiving moderately or highly emetogenic chemotherapy", 
he added. "We have previously shown that a single dose of 
palonosetron effectively prevented CINV, with prevention rates higher
than those obtained with the historical 5-HT3 receptor antagonists. 
The objective of this study was to evaluate whether a subsequent dose
of palonosetron may result more effective than a single dose 
administration in controlling CINV after multiday chemotherapy 
regimens", Pinto explained. "And it did, impressively. Despite the 
emesis control achieved with a single dose, nausea was still 
experienced by about half of the patients. The administration of the 
second dose minimized the negative effects of nausea in the delayed 
phase thus leading to a significant amelioration of patient's quality
of life in the overall period", he concluded. 60 patients with 
diagnosis of lymphoma, myeloma, sarcoma, acute leukemia, and breast 
cancer were accrued. They were all receiving multiday chemotherapy 
regimens. The first cohort (30 patients) received a single dose of 
palonosetron (0.25 mg i.v.) plus dexamethasone (8 mg) half an hour 
before starting HDT; the second cohort (30 patients) received a 
second dose of palonosetron plus dexamethasone after 48 hours.
The results showed no significant differences between the two 
groups as to acute CINV evaluation, since 98% of patients achieved a 
complete response (no emesis, no need for rescue therapy). Only 17 
patients (28%) experienced moderate nausea. Double-dose palonosetron 
displayed a trend for a better control of delayed nausea, which 
occurred in 77% of patients versus 53% of those treated with a single
dose (p=0.0581). In addition, double palonosetron dosing had a highly
significant impact on nausea- related modifications of daily 
activities as self-assessed by patients at 120 hours from starting of
HDT.
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 (Aloxi®, Onicit®, Paloxi®)
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 (0.25 mg) provides better 
protection from CINV than first-generation 5-HT3 receptor antagonists
throughout a 5-day post-chemotherapy period*. According to the NCCN 
(National Comprehensive Cancer Network) Guidelines palonosetron is 
the preferred 5-HT3 receptor antagonist to be used in a combined 
regimen with an NK-1 antagonist and dexamethasone to prevent nausea 
and vomiting induced by Highly Emetogenic Chemotherapy (HEC). 
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 more than 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 Group of Switzerland 
and today it is marketed as Aloxi®, Onicit®, and Paloxi® in more than
40 countries world-wide. Palonosetron, marketed as Aloxi®, 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 refer to Moderately Emetogenic Chemotherapy (MEC) 
setting
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

Contact:

Helsinn Healthcare SA
Paolo Ferrari
Head of International Marketing
Tel.: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com

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