LifeCycle Pharma Announces Positive Phase I Clinical Results for its Transplantation Product Candidate

LCP-Tacro Heads into US Phase II Clinical Trials for Organ Transplantation

04-Jun-2007

LifeCycle Pharma A/S announced positive results from its Phase I clinical trial program of LCP-Tacro, a proprietary, once-daily tacrolimus tablet. A series of Phase I trials, involving more than 150 healthy volunteers demonstrate that LCP-Tacro has a once-daily profile, delivers consistently higher bioavailability of about 50% compared to Prograf(R), and reduces peak levels (Cmax) and reduces peak (Cmax)/trough (Cmin) fluctuation compared to Prograf(R).

LifeCycle Pharma has conducted a series of Phase I studies in more than 150 healthy volunteers to demonstrate the profile of LCP-Tacro under single-dose and multi-dose (steady-state) conditions. In addition to this, dose-linearity, food-effect and diurnal pharmacokinetic studies have been completed.

Tacrolimus is an immunosuppressive medication to prevent rejection after organ transplantation. LCP-Tacro is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability and reduced variability compared to both Astellas' twice daily version of tacrolimus (Prograf(R)) and its modified-release version of tacrolimus for organ transplants. This is expected to represent significant improvements for the patients.

Other news from the department research and development

Most read news

More news from our other portals

Fighting cancer: latest developments and advances