Helsinn Announces Top-Line Results of its Phase IIb Trial With Elsiglutide for the Prevention of Chemotherapy-induced Diarrhea in Colorectal Cancer Patients - Seite 2

Helsinn is working on potential options for the further development of elsiglutide. The company will evaluate the full set of data generated from the Phase IIb trial and discuss the results with medical experts with the objective of fully understanding the outcome for elsiglutide and evaluate next possible steps.

About chemotherapy-induced diarrhea (CID) 

Diarrhea is one of the most debilitating side effects associated with cancer treatment. CID is associated with weight loss, malnutrition, fatigue, loss of fluids and electrolytes imbalance that, in case of persistent and severe diarrhea, can result in life-threatening dehydration, renal insufficiency, and may contribute to cardiovascular morbidity. The incidence and severity of CID varies considerably with the nature and dose of the cytotoxic therapy and frequencies. A high incidence of diarrhea of any grade (between 30-80%) has been reported in colorectal cancer patients receiving chemotherapeutic agents containing 5- Fluorouracil (5-FU) alone or in combination with oxaliplatin or irinotecan. Other chemotherapeutic agents commonly administered to patients with lung, breast or neuroendocrine cancers may cause diarrhea to a lesser extent.

The occurrence of CID has a potential negative impact on the compliance of patients with their chemotherapy regimens and schedules, which can result in a delay in therapy, dosage reduction or discontinuation of therapy.  Changes to chemotherapy treatment resulting from CID may ultimately affect the patient's clinical outcome, and impact on overall health care resource consumption. The occurrence of CID can significantly impair patients' quality of life.  

About Elsiglutide 

Elsiglutide is a novel, potent and selective GLP-2 analogue invented by Zealand for the prevention of chemotherapy-induced diarrhea (CID).  GLP-2 is a native peptide, secreted upon ingestion. It plays a key role in intestinal growth and tissue formation by promoting regeneration of the epithelial surface of the digestive system.

Elsiglutide is under development by Helsinn as a potential first-ever therapy against chemotherapy-induced diarrhea.  

Global development and commercial rights to elsiglutide for its use in cancer supportive care outside the Nordic countries are licensed to Helsinn (www.helsinn.com).

About the Phase IIb dose-ranging trial with elsiglutide 

The trial was a randomized, stratified, double-blind, double-dummy, parallel group, placebo-controlled, dose finding, multicenter, multinational, Phase IIb trial in patient with colorectal cancer receiving 5-fluorouracil (5-FU)-based chemotherapy (FOLFOX or FOLFIRI).  Patients received, starting from the day of chemotherapy administration, a single daily dose subcutaneously of elsiglutide 10, 20 or 40 mg or placebo for four consecutive days.  Each patient was in the study for three consecutive chemotherapy cycles. The treatment period for each patient was four consecutive days of the first two chemotherapy cycles.