FDA approval puts Zealand Pharma drug into Phase I study  

2007.09.17
The FDA approves an application for ZP1846 to be administered to humans, enabling initiation of a Phase I study of the drug designed to reduce diarrhoea problems in chemotherapy patients
The FDA has approved an application from Danish biopharmaceutical company Zealand Pharma for its candidate drug ZP1846 to be administered to humans. The peptide has been developed for prevention and treatment of severe diarrhoea induced by chemotherapy, which affects patients on many anti-cancer therapies.
 
Zealand Pharma will now initiate a Phase I clinical study in healthy volunteers, which will take place in the United States. Pre-clinical studies have shown that ZP1846 helps prevent diarrhoea by lessening the damaging effects of chemotherapy on the lining of the small intestine.
 
CEO Eva Steiness comments: “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."
 
Zealand Pharma's pipeline now includes seven compounds in pre-clinical or clinical development, three of which have been licensed by the pharmaceutical companies Wyeth and Sanofi-Aventis.
 
Founded in 1998 and currently employing 65 people, Copenhagen-based Zealand Pharma focuses on discovery and development of novel peptide based drugs. Its investors include BankInvest, LD Pensions, Dansk Erhvervsinvestering and Vækstfonden as well as the international biotech investors CDC Entreprises Innovation and AGF Private Equity (both in Paris) and Life Sciences Partners (Amsterdam). The news was reported on Zealand Pharma's website.
 
Link > Zealand Pharma  

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