FDAnews
www.fdanews.com/articles/101722-lifecycle-begins-trial-for-immunosuppressant-candidate

LifeCycle Begins Trial for Immunosuppressant Candidate

December 3, 2007

Denmark’s LifeCycle Pharma has started a Phase II trial for LCP-Tacro, an immunosuppressant to prevent organ rejection in liver transplant recipients.

The open-label, multicenter trial in up to 50 transplant patients will compare the pharmacokinetics and safety of once-daily LCP-Tacro (tacrolimus) tablets versus twice-daily Prograf (tacrolimus) capsules.

At the conclusion of the trial, eligible patients will be given the opportunity to participate in a 52-week, open-label extension study in which they will receive LCP-Tacro.

Lifecycle said it expects results in the first half of 2008.