Enrolment complete in Veloxis LCP-Tacro Phase III study in de novo kidney transplant patients

Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that enrolment has been completed in its pivotal LCP-Tacro Phase III study in de novo kidney transplant patients. The LCP-Tacro 3002 study is designed to demonstrate non-inferiority versus the gold standard therapy Prograf® and has randomized over 540 patients at approximately 90 clinical sites around the world.

"With the results of our 3001 study already complete and our 3002 study fully enrolled, we have completed enrolment in our LCP-Tacro Phase 3 registration trials. This puts Veloxis firmly on track for submission of a New Drug Application (NDA) next year," says Bill Polvino CEO and President of Veloxis Pharmaceuticals. Given the data collected to date, Veloxis hopes that LCP-Tacro, once approved, will provide additional options for kidney transplant patients facing possible organ rejection.

Study 3002 is a randomized, double-blind, multi-centre study that compares once-daily LCP-Tacro against twice-daily Prograf in de novo adult kidney transplant patients. The primary endpoint of the study, a composite endpoint (BPAR (Biopsy Proven Acute Rejection), graft failure, loss to follow up or death), will be evaluated after a 12-month treatment period to demonstrate the non-inferiority of LCP-Tacro compared to Prograf. Secondary endpoints will include safety, tolerability and renal function assessments. The study is being conducted at approximately 90 transplant centres, primarily in the U.S. and Europe. Patients will participate in a 12-month extension period on treatment for follow-up safety assessments.