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FDA has approved Zealand Pharma's Investigative New Drug application |
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07 Sep 2007 |
Zealand Pharma advances ZP1846 into Phase I clinical trials. ZP1846, a peptide which incorporates Zealand’s proprietary SIP technology, is developed as a therapy for the prevention and treatment of chemotherapy-induced diarrhoea, a debilitating adverse reaction affecting patients undergoing treatment with many anti-cancer therapies
COPENHAGEN, Denmark | September 6, 2007 | The Phase I study will be a double-blind, placebo controlled, randomized, escalating intravenous single dose safety and tolerability study in healthy volunteers and takes place in the United States.
Zealand’s pre-clinical studies have demonstrated that ZP1846 inhibits chemotherapy-induced injury in the small intestine, and consequently, it also reduces the incidence of chemotherapy-induced diarrhoea. It is anticipated that the use of ZP1846 in patients undergoing chemotherapy may ameliorate the destructive effects of the chemotherapy on the small intestine and reduce the severity of diarrhoea.
Today, serious gastrointestinal side effects are observed in up to 50% of patients undergoing certain forms of chemotherapy, which in turn may require dose modification or cessation of cancer chemotherapy
Eva Steiness , Chief Executive Officer, commented: “Advancing ZP1846 into clinical trials further strengthens our development pipeline. Zealand Pharma has applied its knowledge of peptide optimization and its proprietary SIP technology to develop a series of novel peptides that specifically enhance the growth and function of the lining of the small intestine.
Chemotherapy-induced diarrhoea can be a serious debilitating adverse reaction affecting patients undergoing treatment with anti-cancer therapies and the gastrointestinal injury may lead to serious complications such as uptake of intestinal bacteria into the blood stream (sepsis), dehydration and kidney insufficiency. There is a strong need for drugs that are able to prevent or treat the mucosal damage and eliminate the diarrhoea induced by chemotherapy, and we believe that ZP1846 is a promising drug candidate for the treatment of chemotherapy-induced diarrhoea”.
SOURCE: Zealand Pharma |
