LifeCycle Pharma Initiates Phase II Clinical Trial for LCP-Tacro, an Immunosuppressant to Prevent Organ Rejection in Liver Transplant Recipients - Health News - redOrbitLifeCycle Pharma A/S (OMX: LCP) (the "Company" or "LCP"), an emerging specialty pharmaceutical company, today announced that it has initiated a Phase II clinical trial for LCP-Tacro, an immunosuppressant to prevent organ rejection in liver transplant recipients. The clinical trial is expected to enroll up to 50 patients in up to 12 centers throughout the U.S. The Company expects to report clinical trial results in the first half of 2008 (1H08). Transplant patients need to maintain a minimum level of tacrolimus in the blood to prevent organ rejection, but too high levels increase the risk of serious side effects such as kidney damage or hypertension. Therefore, tacrolimus levels need to be managed carefully and transplant patients typically are obliged to make frequent visits to the hospital for monitoring and dose adjustments for months after receiving a new organ. Management of tacrolimus levels is complicated by the low bioavailability of Prograf, its variable absorption and interaction with food and other drugs. The current market size for immunosuppressants used in transplantation in the seven major markets (US, Japan, France, Germany, Italy, Spain and UK) is approximately $3.3B and growing by approximately 5-10% per year.
