LifeCycle Pharma to initiate Phase II clinical trial of LCP-Tacro for organ transplantation

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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.

The FDA has reviewed the clinical trial protocol, 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 the end of 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.

Kidney transplantation is normally recommended for patients with end-stage kidney disease or kidney failure caused by severe, uncontrolled hypertension, diabetes, infections, intoxication or inflammation. Kidney transplants generally offer the best outlook for patients with end-stage kidney disease. Most centers have patient and organ survivals of over 90% at one year, and more than 80% at three years. Approximately 50% of transplanted kidneys are still functional after 10 to 15 years.