LifeCycle Pharma Announces Positive Results of Phase 2 Clinical Trial for LCP-Tacro™ in De Novo Liver Transplant Patients

HORSHOLM, Denmark, Jan. 6, 2011 /PRNewswire/ -- 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."

LCP-Tacro™ Phase 3 clinical program in kidney transplant patients

The Phase 3 development program for LCP-Tacro™ consists of an ongoing, fully-enrolled study in 326 patients with stable kidney transplants along with an ongoing Phase 3 study in de novo kidney transplant patients under a Special Protocol Assessment (SPA) that was agreed to with the U.S. Food and Drug Administration (FDA) in August 2010.  Data from the fully-enrolled Phase 3 study in stable kidney transplant patients is expected to be announced in mid-2011.  Treatment of the first patient in the de novo kidney transplant study was announced in October 2010, and results are expected in 2012.

Summary of LCP-Tacro™ (de novo Liver) Phase 2 Clinical Trial Design

The above Phase 2 clinical trial was an open-label, multi-center, prospective, parallel group study in de novo liver transplant patients. The objectives of the study were to determine the pharmacokinetic profile (AUC0-24, Cmax, Cmin, and Tmax), safety and efficacy of LCP-Tacro™ tablets once-daily versus Prograf® capsules twice-daily.  De novo liver transplant candidates who fulfilled all inclusion/exclusion criteria were randomized to receive either LCP-Tacro™ or Prograf® following their liver transplantation. A 24-hour pharmacokinetic (PK) profile assessment was performed on Study Days 1, 7 and 14. Patients continued in the one year maintenance stage of the study to evaluate the long-term safety and efficacy of LCP-Tacro™ versus Prograf®.

About LCP-Tacro™ and tacrolimus

Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP-Tacro™ is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak-to-trough variability when compared to currently approved tacrolimus products. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity and opportunistic infections. Therefore, tacrolimus levels need to be managed carefully, and transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments after receiving a new organ.

About LifeCycle Pharma A/S (LCP)

Based in Horsholm, Denmark, with an office in New Jersey, LCP is a specialty pharmaceutical company. Clinical development is the core of LCP's efforts to develop a product portfolio which includes the Company's lead product candidate, LCP-Tacro™, for immunosuppression, specifically organ transplantation, and products to combat certain cardiovascular diseases. LCP adapts new technologies on a fast commercial timetable. LCP's unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability - at low-scale up costs - not only for a broad spectrum of drugs already on the market but also for new chemical entities. LCP has a lipid lowering product, Fenoglide®, currently on the U.S. market and a diversified near and medium term pipeline with three clinical stage product candidates and a number of projects in preclinical development. LCP is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: LCP.  For further information, please visit www.lcpharma.com.

SOURCE LifeCycle Pharma A/S