LifeCycle Pharma Moves LCP-Tacro™ into Clinical Phase 3
News Dec 30, 2008
LifeCycle Pharma A/S has announced the enrollment of the first patient in its Phase 3 clinical trial program for use of LCP-Tacro™ in the prevention of organ rejection in stable kidney transplant patients.
The clinical trial protocol has been reviewed by FDA, and LCP expects to enroll approximately 300 stable kidney transplant patients in the program. The study will be conducted at approximately 50 sites in U.S. and Europe and the clinical trial results are expected by second half of 2010.
After having demonstrated positive Phase 2 pharmacokinetic (PK) data in stable transplant patients earlier this year, LCP had successful discussions with the U.S. Food and Drug Administration (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 (Prograf®) in de novo transplant patients. The pivotal clinical program in liver patients awaits discussions with FDA in the first half of 2009.
”The initiation of the clinical Phase 3 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,” says Dr. Karin Hamberg, Executive Vice President of R&D and CMO of LCP.