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.
In order to prevent the patient's immune system from rejecting the transplanted organ, immunosuppression t herapy is required for the lifetime of the graft with a base maintenance drug and adjunctive therapies. In 2005, over 50,000 solid organ transplants were conducted in the 7 major markets (US, Japan, France, Germany, Italy, Spain and UK). The number of transplant procedures is expected to grow steadily every year; however, the number of patients waiting for transplants is predicted to grow even faster, as there is a lack of organs. The current market size for immunosuppresssants used in transplantation in the 7 major markets is approximately $3.3bn and is estimated to grow by approximately 5-10% per year.
Tacrolimus is a leading immunosuppressive medication to prevent rejection after organ transplantation. LCP-Tacro is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability and reduced variability compared to both Astellas' twice daily version of tacrolimus (Prograf(R)) and its modified-release version of tacrolimus for organ transplants. This is expected to represent significant improvements for the patients.
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 the tacrolimus levels is complicated by the low bioavailability of Prograf(R), its variable absorption and interaction with food and other drugs.
About LifeCycle Pharma A/S:
LifeCycle Pharma, headquartered in H0rsholm, Denmark, is an emerging pharmaceutical company with a broad and late stage product pipeline in therapeutic areas of cholesterol management, hypertension, organ transplant and autoimmune diseases. LifeCycle Pharma's product ca ndidates are proprietary and designed to improve the quality of existing drugs by enhancing the release and absorption of drugs in the human body. LifeCycle Pharma's proprietary technology platform, MeltDose(R) technology, offers lower dosing, reduced side effects and improved safety and patient compliance, as well as reduced product development time and development costs. LifeCycle Pharma is listed on the OMX Nordic Exchange under the trading symbol (LCP). Please visit www.lcpharma.com for further information about LifeCycle Pharma A/S.
CONTACT: For further information please contact: LifeCycle Pharma A/S,Michael Wolff Jensen, Executive Vice President and CFO, Tel.+45-40-74-62-44
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