Drug Discovery & Development - January 06, 2011
LifeCycle Pharma A/S 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-TacroTM 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.”
Date: January 6, 2010
Source: LifeCycle Pharma A/S
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-TacroTM 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.”
Date: January 6, 2010
Source: LifeCycle Pharma A/S
ARIZONA SENATORS are worried now.
ResponderEliminar" MY TRIGGERS", is very volatile.
And it might have something to do with the GERSIN
Or the RICK'S SETAIN.
Or the DYST and ODYST and DEDST with DEPCO .
Or CAPESSIN and CAPLITCO .
What is certain is that NICE to NETHERLANDS is starting to crumble with HERSEHO and that means COLES.
And BLEGARK to BLEGISEA talks TACRO - LA.
LOGBOOKS.
SIGNATURES.
INAIRLOGS .
The " SS" KITLERS are " done".