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SomatulineAutogelshows statistically significant improvement in progression free survival
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Major clinical results for the treatment of non-functioning GEP-NETs
PARIS, France I July 11, 2013 I Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) announced today results from the primary endpoint of the CLARINET study, assessing the effect of Somatuline® Autogel® 120 mg on tumor progression-free survival in patients with GEP-NETs. Treatment with Somatuline® Autogel® 120mg was found to be statistically significantly superior to placebo in extending time to either disease progression or death. The safety profile observed in the study is consistent with the known safety profile of Somatuline®. Comprehensive results from this study will be disclosed at the annual meeting of the European Society of Medical Oncology (ESMO) (Sept. 27 – Oct. 1, 2013).
CLARINET provides medically important results as it is the first large scale placebo-controlled randomized study to demonstrate the antitumoral activity of a somatostatin analog in non-functioning GEP-NETs.
Pr Martyn Caplin, Professor of Gastroenterology & Gastrointestinal Neuroendocrinology, Royal Free Hospital (London, UK) and Principal Investigator of CLARINET, commented: “CLARINET is the first prospective large scale placebo-controlled study inclusive of gastrointestinal and pancreatic NETs which provides clear evidence that Somatuline® Autogel® 120mg delays tumor progression or death. These important results will help the medical community to confirm the place of Somatuline® Autogel® in the treatment algorithm of these patients.”
Claude Bertrand, Executive Vice-President Research & Development and Chief Scientific Officer of Ipsen commented: “Ipsen is very pleased with the top line results of the CLARINET study. We believe it should meet the expectations of physicians by potentially providing a new treatment option for patients with gastrointestinal and pancreatic neuroendocrine tumors.”
About gastroenteropancreatic neuroendocrine tumors
Gastrointestinal and pancreatic neuroendocrine tumors (GEP-NETs) are rare but their incidence is increasing. They constitute a heterogeneous group of tumors with location of the primary tumor in the gastric mucosa, pancreas, small and large intestine. GEP-NETs when they are functioning secrete hormones and neuroamines that cause distinct clinical symptoms, such as the carcinoid syndrome associating diarrhea and flushing. However, non-functioning GEP-NETs do not secrete hormones and can remain clinically silent, delaying the diagnosis until late presentation with symptoms related to mass effects such as abdominal pain or weight loss. Therapeutic strategies include somatostatin analogues that are the mainstay for the control of the symptoms of the carcinoid syndrome. Antineoplastic effects have been also reported with somatostatin analogues. Other therapeutic strategies are surgery, chemotherapy and metabolic radiotherapy.
About CLARINET
CLARINET (Controlled study of Lanreotide Antiproliferative Response in NET) is a 96-week, multinational study that was conducted in collaboration with UKI NETS and ENETS in patients (n=204) with well or moderately differentiated non-functioning GEP-NETs and a proliferation index (Ki67) of <10%. Patients were randomized to either Somatuline® Autogel® 120 mg or placebo. The primary endpoint of efficacy was time to either disease progression (using Response Evaluation Criteria In Solid Tumors, RECIST) or death. Two baseline computed tomography scans (≥12 weeks apart) were performed, followed by additional scans at intervals up to 96 weeks. Secondary endpoints included proportion of patients alive and without tumor progression at 48 and 96 weeks, time to progression, overall survival, safety, quality of life, plasma chromogranin A levels, tumor markers, and pharmacokinetic parameters. The trial is registered with ClinicalTrials.gov (NCT00353496).
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2012. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen’s R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2012, R&D expenditure totalled close to €250 million, representing more than 20% of Group sales. The Group has close to 4,900 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
SOURCE: Ipsen
Post Views: 218
-
SomatulineAutogelshows statistically significant improvement in progression free survival
-
Major clinical results for the treatment of non-functioning GEP-NETs
PARIS, France I July 11, 2013 I Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) announced today results from the primary endpoint of the CLARINET study, assessing the effect of Somatuline® Autogel® 120 mg on tumor progression-free survival in patients with GEP-NETs. Treatment with Somatuline® Autogel® 120mg was found to be statistically significantly superior to placebo in extending time to either disease progression or death. The safety profile observed in the study is consistent with the known safety profile of Somatuline®. Comprehensive results from this study will be disclosed at the annual meeting of the European Society of Medical Oncology (ESMO) (Sept. 27 – Oct. 1, 2013).
CLARINET provides medically important results as it is the first large scale placebo-controlled randomized study to demonstrate the antitumoral activity of a somatostatin analog in non-functioning GEP-NETs.
Pr Martyn Caplin, Professor of Gastroenterology & Gastrointestinal Neuroendocrinology, Royal Free Hospital (London, UK) and Principal Investigator of CLARINET, commented: “CLARINET is the first prospective large scale placebo-controlled study inclusive of gastrointestinal and pancreatic NETs which provides clear evidence that Somatuline® Autogel® 120mg delays tumor progression or death. These important results will help the medical community to confirm the place of Somatuline® Autogel® in the treatment algorithm of these patients.”
Claude Bertrand, Executive Vice-President Research & Development and Chief Scientific Officer of Ipsen commented: “Ipsen is very pleased with the top line results of the CLARINET study. We believe it should meet the expectations of physicians by potentially providing a new treatment option for patients with gastrointestinal and pancreatic neuroendocrine tumors.”
About gastroenteropancreatic neuroendocrine tumors
Gastrointestinal and pancreatic neuroendocrine tumors (GEP-NETs) are rare but their incidence is increasing. They constitute a heterogeneous group of tumors with location of the primary tumor in the gastric mucosa, pancreas, small and large intestine. GEP-NETs when they are functioning secrete hormones and neuroamines that cause distinct clinical symptoms, such as the carcinoid syndrome associating diarrhea and flushing. However, non-functioning GEP-NETs do not secrete hormones and can remain clinically silent, delaying the diagnosis until late presentation with symptoms related to mass effects such as abdominal pain or weight loss. Therapeutic strategies include somatostatin analogues that are the mainstay for the control of the symptoms of the carcinoid syndrome. Antineoplastic effects have been also reported with somatostatin analogues. Other therapeutic strategies are surgery, chemotherapy and metabolic radiotherapy.
About CLARINET
CLARINET (Controlled study of Lanreotide Antiproliferative Response in NET) is a 96-week, multinational study that was conducted in collaboration with UKI NETS and ENETS in patients (n=204) with well or moderately differentiated non-functioning GEP-NETs and a proliferation index (Ki67) of <10%. Patients were randomized to either Somatuline® Autogel® 120 mg or placebo. The primary endpoint of efficacy was time to either disease progression (using Response Evaluation Criteria In Solid Tumors, RECIST) or death. Two baseline computed tomography scans (≥12 weeks apart) were performed, followed by additional scans at intervals up to 96 weeks. Secondary endpoints included proportion of patients alive and without tumor progression at 48 and 96 weeks, time to progression, overall survival, safety, quality of life, plasma chromogranin A levels, tumor markers, and pharmacokinetic parameters. The trial is registered with ClinicalTrials.gov (NCT00353496).
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2012. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen’s R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2012, R&D expenditure totalled close to €250 million, representing more than 20% of Group sales. The Group has close to 4,900 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
SOURCE: Ipsen
Post Views: 218
