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Helsinn Healthcare SA

Single dose Palonosetron prevents emesis induced by chemotherapy in non Hodgkin's lymphoma patients

Berlin, Germany (ots)

Single dose palonosetron is effective and
safe in preventing chemotherapy-induced nausea and vomiting (CINV) in
patients with aggressive non-Hodgkin's lymphomas who undergo 
moderately emetogenic chemotherapy. Data presented today at the 
European Haematology Association Congress in Berlin, Germany
New data presented today at the EHA (European Haematology 
Association) Congress in Berlin show that a single dose of 
palonosetron, a second generation 5-HT3 receptor antagonist, is 
effective and safe in preventing chemotherapy-induced nausea and 
vomiting (CINV) in patients with aggressive non Hodgkin's lymphoma 
(NHL), treated with cytotoxic agents.
The result comes from a study conducted in Italy on behalf of the 
Italian Group of Study on Lymphomas (GISL) by a multicentric team 
coordinated by Dr. Nicola Di Renzo of the Vito Fazzi Hospital of 
Lecce. "The standard approach in the antiemetic therapy in NHL is 
represented by antiserotoninergic drugs. Palonosetron is a selective 
and potent serotonin antagonist that associated to the chemotherapy 
of solid tumours has demonstrated improved efficacy compared to older
5-HT3 receptor antagonists. The objective of our study was to 
evaluate the efficacy and safety of a single dose of palonosetron in 
preventing CINV induced by moderately emetogenic chemotherapy (MEC) 
agents used for the treatment of aggressive NHL", explained Dr. Di 
Renzo.
"Palonosetron, given as antiemetic treatment, is effective and 
safe in preventing CINV in patients with aggressive NHL", he 
concluded. The GISL study was an open-label, multicenter phase II 
study assessing the efficacy of a single dose of palonosetron (0.25 
mg) prior to the administration of chemotherapy in the first day of 
treatment, in ten Italian hospitals. The study included 86 patients, 
affected by aggressive NHL. The primary endpoint was the overall rate
of patients achieving a complete response (CR - defined as no emetic 
episode and no use of rescue medication) during the whole study 
period (0-120 h). Relevant secondary endpoints included: CR in the 
acute (0-24h) and delayed (24-120) phases, no emesis and no nausea 
rates.
The primary endpoint was achieved with a CR rate of 86%. The CR in
the acute and delayed phases was 90.7% and 88.4% respectively. No 
emesis rates were 91.9% (0-24h), 89.5% (24-120h) and 88.4% (0-120h). 
Importantly, nausea, that is still considered an unmet need despite 
the anti emetic treatments, was very well controlled by a single 
palonosetron dose with no nausea rates of 84.9%, 75.6% and 74.4% in 
the acute, delayed and overall periods respectively. No serious drug 
related adverse events were reported. "These results are of special 
interest for both physicians and patients", pointed out Prof. Mauro 
Bianchi, Medical Development Director at Helsinn, the Swiss 
pharmaceutical group developer and worldwide licensor of 
palonosetron. "Generally, NHL patients undergoing moderately 
emetogenic chemotherapy based on CHOP or CHOP-R protocols, including 
daily dose of 100 mg of prednisone orally from day 1 to day 5 - show 
CINV rates around 40-50%. In this study, palonosetron reduced this 
percentage to 14%", he concluded.
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 selective 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 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 Group of Switzerland and 
today it is marketed as Aloxi®, Onicit®, and Paloxi®. 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
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:

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

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