LifeCycle Pharma Submits the Phase 3 Protocol for LCP-Tacro(TM) (De No Kidney) to the FDA

COPENHAGEN, Denmark, Dec. 23, 2009 (GLOBE NEWSWIRE) -- LifeCycle Pharma A/S (Copenhagen:LCP) announced today that LCP has submitted the phase 3 protocol for LCP-Tacro(TM) in de novo kidney transplant recipients to the Food and Drug Administration in United States ("FDA"). LCP will review the protocol with the Agency and expects that enrollment of patients will begin near the middle of 2010. The upcoming Phase 3 study in de novo kidney transplant patients will run in parallel with LCP's current ongoing Phase 3 study in stable kidney transplant patients.

Back to news