Jan 7 2011
LifeCycle Pharma A/S (OMX: LCP) has announced positive top-line results from a Phase 2 clinical trial involving 58 patients comparing LCP-Tacro™ tablets administered once-daily versus Prograf® (tacrolimus) capsules (Astellas Pharma) administered twice-daily in de novo liver transplant patients for one year. These data confirm the previous positive experience with LCP-Tacro™ in stable kidney and liver transplant patients and support comparability of LCP's extended release tablet formulation of tacrolimus when compared to twice-daily Prograf® capsules. Further, the results indicate that LCP-Tacro™ tablets may be safely and efficaciously administered once-daily immediately following a liver transplant.
Results from the 14 day pharmacokinetic (PK) portion of this Phase 2 study have previously been reported in August 2009. After the initial 14 day PK period, patients were maintained on either LCP-Tacro™ or Prograf® for one year to assess longer-term safety and efficacy in a comparative setting. While not sized and powered to demonstrate safety and efficacy at a statistically relevant level, once-daily LCP-Tacro™ appears to be as well tolerated as the currently approved, immediate release, twice-daily product Prograf®.
"This study was an important milestone for the company as it provides additional evidence of the comparable safety and efficacy of LCP-Tacro™ versus the twice-daily form of tacrolimus," said Dr. William J. Polvino, President and CEO of LifeCycle Pharma. "It is also very encouraging that the safety and efficacy data compared to twice-daily tacrolimus obtained from this trial are very consistent with results seen in prior studies in kidney transplant patients. We are looking forward to completing our two Phase 3 trials in kidney transplant patients and announcing the data from those studies in 2011 and 2012."
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