The company expects that the Phase II clinical trial will provide a robust statistical assessment, confirm the proposed dosing regimen and support the initiation of a Phase III clinical trial in 2008 in de-novo kidney and stable kidney transplant recipients. Top-line results from the Phase II clinical trial are expected by year end 2007 or early 2008.
The Phase II clinical trial, is a three sequence, open-label, multi-center, prospective, conversion study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets once-a-day versus Prograf (tacrolimus) capsules twice-a-day.
Flemming Ornskov, president and CEO of LifeCycle Pharma, said: “The continued growth of our organ transplantation franchise is integral to the success of our business strategy of evolving into a fully integrated specialty pharmaceutical company. LCP-Tacro (kidney) in Phase II and LCP-Tacro (liver) nearing Phase II, demonstrates the successful execution of our strategy.”