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HORSHOLM, Denmark, May 31, 2007 /PRNewswire-FirstCall/ -- LifeCycle Pharma announces positive Phase I clinical results for its transplantation product candidate, LCP-Tacro - Heads into US Phase II clinical trials for organ transplantation.
Today LifeCycle Pharma A/S (OMX:LCP) announces positive results from its Phase I clinical trial program of LCP-Tacro, a proprietary, once-daily tacrolimus tablet.
A series of Phase I trials, involving more than 150 healthy volunteers demonstrate that LCP-Tacro:
- Has a once-daily profile.
- Delivers consistently higher bioavailability of about 50% compared to Prograf(R).
- Reduces peak levels (Cmax) and reduces peak (Cmax) / trough (Cmin) fluctuation compared to Prograf(R).
"The once-daily profile and significant increase in bioavailability, compared to Prograf(R), that has been demonstrated for our LCP-Tacro product candidate in an extensive Phase I program is encouraging, and provides the foundation to quickly advance it into Phase II trials for organ transplantation, said Dr. Flemming Ornskov, President and CEO of LifeCycle Pharma". LifeCycle Pharma's long-term strategy is to concentrate on and commit significant resources to the development of a number of product candidates for organ transplantation as it moves towards becoming a fully integrated specialty pharmaceutical company" added Dr. Ornskov.
About the studies:
LifeCycle Pharma has conducted a series of Phase I studies in more than 150 healthy volunteers to demonstrate the profile of LCP-Tacro under single-dose and multi-dose (steady-state) conditions. In addition to this, dose-linearity, food-effect and diurnal pharmacokinetic studies have been completed.
About transplantation:
In order to prevent the patient's immune system from rejecting
the transplanted organ, immunosuppression t
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