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news.LifeCycle Pharma has announced positive top-line results from a completed Phase II clinical study of LCP-Tacro tablets in stable liver transplant patients which are in line with earlier data announced for stable kidney transplant patients.
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These new data for LifeCycle Pharma (LCP)-Tacro, a once daily immunosuppression drug to prevent rejection after organ transplantation, demonstrated that LCP-Tacro tablets also have a potential best-in-class profile when compared to the currently marketed twice daily tacrolimus capsule, Prograf, in stable liver patients.
The study results showed that LCP-Tacro tablets improved bioavailability by approximately 30%, leading to a 70% dosing compared to Prograf and reduced variability (peak-to-trough ratio) with a 30% reduced peak in absorption.
According to LCP, the positive Phase II clinical data in stable kidney and liver transplant patients provide a very robust, statistical confirmation of the proposed dosing regimen. With the results from the clinical Phase II program, LCP expects to initiate the Phase III clinical trial program in stable transplant patients by late 2008.
In addition, these data are a solid basis to conduct Phase IIb pharmacokinetic studies in de-novo kidney and liver transplant patients, subsequently leading to Phase III de-novo studies in the first half of 2009.