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

Excellence as a fluorescence microscope for in situ hybridization or as a polarizing microscope

Patient-derived microtumors with preserved immune competence

Where manual cell culture adds noise, automation delivers control

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.

https://www.bionity.com/en/news/65030/lifecycle-pharma-announces-positive-phase-i-clinical-results-for-its-transplantation-product-candidate.html