LifeCycle Pharma will initiate a Phase II clinical trial of LCP-Tacro for the prevention of organ rejection in kidney transplant patients following the update of its initial Investigational New Drug Application (IND) in the United States (U.S.)
LifeCycle Pharma has also reached protocol agreement with the U.S. Food and Drug Administration (FDA) for its first Phase II trial in kidney transplant recipients.
LifeCycle Pharma A/S (OMX:LCP) today announced it will initiate a Phase II clinical trial program using LCP-Tacro to prevent organ rejection in kidney transplant patients. The clinical trial protocol has been reviewed by the FDA, and LifeCycle Pharma has revised it to be in line with FDA recommendations. As a result, LifeCycle Pharma expects to initiate a Phase II clinical trial soon.
The trial is designed as a conversion study in stable kidney transplant recipients, with patients being switched to LCP-Tacro once-a-day from Prograf(R) twice-a-day. Up to 60 patients will be investigated at 10-12 sites in the U.S. and Canada, and the initial clinical trial results are expected by year end 2007, or early 2008. This study is considered to form the basis for initiation of a subsequent Phase III program in de-novo kidney transplant recipients.
A Phase II clinical study in liver transplant recipients is expected to follow this year.
"The initiation of the Phase II study using LCP-Tacro is a step forward in the development of our organ transplantation franchise," said Dr. Flemming Ornskov, President and CEO of LifeCycle Pharma. "We are encouraged by the progress LifeCycle Pharma has made, and eager to advance LCP-Tacro to Phase II clinical trials," added Dr. Ornskov.
"This is the start of an exciting clinical development program. LCP-Tacro will bring the convenience of once-daily administration of tacrolimus and may optimize outcomes after kidney transplantation," said Dr. Shamkant Mulgaonkar, Chief of the Transplant Division at St. Barnabas Healthcare System, Livingston, New Jersey, USA and a clinical investigator in the first Phase II study.