LifeCycle Pharma (LCP) has submitted the phase 3 protocol for LCP-Tacro in de novo kidney transplant recipients, to the FDA. LCP is expected to review the protocol with the Agency and expects that the enrollment of patients will begin near the middle of 2010.
The company said that the upcoming phase 3 study in de novo kidney transplant patients will run in parallel with its current ongoing phase 3 study in stable kidney transplant patients.
The phase 3 clinical trial is planned as a multi-center, prospective, parallel group study in de novo kidney transplant patients. De novo kidney transplant candidates are planned to be randomised to receive either LCP-Tacro or Prograf, following their kidney transplantation.
Tacrolimus is immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP-Tacro is being developed as a once daily tablet version of Tacrolimus, with improved bioavailability and reduced peak-to-trough variability.
The company said that as per regulatory requirements, graft failure, biopsy-proven acute rejection or loss to follow up at 12 months after randomisation will be the primary efficacy outcome.