Helsinn Announces Top-Line Results of its Phase IIb Trial With Elsiglutide for the Prevention of Chemotherapy-induced Diarrhea in Colorectal Cancer Patients - Seite 3

Two populations were planned for this study. The population receiving FOLFOX or FOLFIRI without monoclonal antibody was defined as the target population (at least 120 patients per treatment group, for a total of 480 patients), while the population concomitantly receiving monoclonal antibody was defined as the additional population (up to 30 patients per treatment group, total maximum of 120 patients). The primary endpoint was the proportion of patients with diarrhea of grade >2 or more during the first cycle of chemotherapy. The primary analysis took into consideration only the target population.

About the Helsinn Group 

Helsinn is a privately owned cancer supportive care pharmaceutical group with an extensive portfolio of marketed products and a broad development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality, through a unique integrated licensing business model working with long standing partners in pharmaceuticals, medical devices and nutritional supplement products. Helsinn is headquartered in Lugano, Switzerland, with operating subsidiaries in Ireland and the United States, a representative office in China, as well as a product presence in about 90 countries globally.

For more information, please visit www.helsinn.com

About Zealand Pharma A/S 

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotech company with leading scientific expertise in turning peptides into medicines. Zealand has a growing proprietary pipeline of novel investigational medicines and a portfolio of products and projects under license collaborations with Sanofi, Helsinn and Boehringer Ingelheim.

The company's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analogue for the treatment of type 2 diabetes, is licensed to Sanofi who markets the product globally (ex-US) as Lyxumia® and has it under regulatory review in the US. The license agreement with Sanofi covers also a fixed-ratio combination of lixisenatide with basal insulin glargine (Lantus®) under regulatory review in both the US and Europe.  

Zealand's proprietary pipeline of product candidates includes: ZP4207 (single-dose rescue treatment) for acute, severe hypoglycemia (Phase II); ZP1848 for Short Bowel Syndrome (Phase II); ZP4207 (multiple-dose version) for better hypoglycemia management in diabetes (Phase I); ZP2929 for diabetes/obesity (Phase I); and several preclinical peptide therapeutics.

The company is based in Copenhagen (Glostrup), Denmark. For further information about Zealand's business and activities, please visit: www.zealandpharma.com or follow us on Twitter @ZealandPharma

 

For more information, please contact:

Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
Tel: [phone]
[e-mail]