LifeCycle Pharma A/S
LifeCycle Pharma Moves LCP-Tacro™ into Clinical Phase 3
Published in Medical Letter on the CDC and FDA, January 18th, 2009
LifeCycle Pharma A/S (OMX:LCP) announced the enrollment of the first patient in it’s 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...
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