LifeCycle Pharma initiates enrollment in Phase III kidney transplant trial

The clinical trial protocol has been reviewed by the FDA, and LifeCycle Pharma (LCP) expects to enroll approximately 300 stable kidney transplant patients in the program. The study will be conducted at approximately 50 sites in the US and Europe and the clinical trial results are expected by second half of 2010.

After having demonstrated positive Phase II pharmacokinetic (PK) data in stable transplant patients earlier in 2008, LCP had successful discussions with the FDA regarding the further development of LCP-Tacro once-daily tablets. The FDA acknowledged the company’s strategy of submitting a 505(b)2 application for LCP-Tacro, thereby making use of existing literature data to support the application for prevention of organ rejection in kidney and liver transplant patients.

To further support the safety database and potentially best in class pharmacokinetic profile for LCP-Tacro, LCP agreed with the FDA to perform PK-studies in de novo kidney and liver transplants.

The results from these ongoing studies, which are expected in first half of 2009, are expected to confirm the superior pharmacokinetic profile of LCP-Tacro over existing tacrolimus formulations in de novo transplant patients. The pivotal clinical program in liver patients awaits discussions with the FDA in the first half of 2009.

Karin Hamberg, executive vice president of R&D at LifeCycle Pharma, said: “The initiation of the clinical Phase III program for LCP-Tacro tablets is a significant step forward in the development of our organ transplantation program as well as in our plans to become a specialty pharmaceutical company. The team has done a tremendous effort to get us to this stage and we all feel proud of having achieved this important milestone.”