Published on September 30, 2009 at 3:06 AM
LifeCycle Pharma A/S (CSE:LCP) today announced positive results from a completed 12 month extension phase of the Phase 2 clinical study of LCP-Tacro tablets in stable liver transplant patients. LCP-Tacro is a once daily immunosuppression drug to prevent rejection after organ transplantation. These new data demonstrated that LCP-Tacro tablets for stable liver patients continues in the extension phase of the study to have a potential best-in-class profile when compared to the currently marketed twice daily tacrolimus capsule, Prograf®, by maintaining
- the once daily administration,
- Improved bioavailability by approximately 30%, leading to a 70% dosing compared to Prograf® in the initial part of the study
- Reduced variability (peak-to-trough ratio) with a 30% reduced peak
According to LCP, the positive data from the 12 month extension phase of the Phase 2 study in stable liver transplant patients provide a confirmation of the proposed dosing regimen. With the results announced today as well as the results announced in August 2009 from the clinical Phase 2b pharmacokinetic studies, LCP can now initiate discussions with the FDA regarding the design and the timing of the phase 3 program for liver transplant patients.
LCP‐Tacro (Liver) Phase 2 Clinical Study Design
The initial Phase 2 clinical study, which commenced enrollment in December 2007, enrolled a total of 57 patients in multiple sites in the U.S. and was a three sequence, open-label, multi‐center, prospective, conversion study in stable liver 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. Stable liver transplant patients who fulfill all I/E (inclusion/exclusion) criteria were enrolled and kept on Prograf® for 7 days, followed by a 14-day treatment period with LCP-Tacro tablets. Pharmacokinetic assessment was performed on Day 7 (Prograf®) and Day 14 & 21 (LCP-Tacro). On Day 22, patients were offered to enroll in the 52‐week open‐label extension study. In total 49 continued in the 12 month extension phase of the study in a LCP-Tacro arm only.
Source: LifeCycle Pharma