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news.Phase III studies in de novo kidney transplants to run parallel with ongoing Phase III studies in stable kidney transplant patients
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LifeCycle Pharma, a specialty pharmaceutical company, has reported positive interim results from a Phase II clinical trial involving 63 patients comparing LCP-Tacro tablets administered once daily versus Prograf capsules, administered twice daily in de novo kidney transplant patients.
These data confirm the previous experience with LCP-Tacro in stable kidney and liver transplant patients announced in March and July 2008, respectively. The results demonstrate that over the first 14 days of the pharmacokinetic study stage within the early post-operative period following a kidney transplant, LCP-Tacro tablets can be safely and efficaciously administered once-daily to de novo kidney transplant patients.
These findings are further supported by interim preliminary six-month follow-up data as the randomized transplant patients have progressed into the one-year maintenance stage of the study. Patients will continue in the one year maintenance stage of the study to evaluate the long-term safety and efficacy of LCP-Tacro versus Prograf.
LifeCycle Pharma (LCP) will draw on these emerging data to form the basis for LCP’s planning and preparation of the pivotal Phase III study in de novo kidney transplant patients and will consult with the FDA with the goal to submit a final Phase III protocol in the second half of 2009.
The Phase III program will evaluate the use of LCP-Tacro with mycophenolate mofetil and corticosteroids compared to the FDA-approved standard treatment of mycophenolate mofetil in combination with cyclosporine and corticosteroids in de novo kidney transplant patients. The upcoming Phase III studies in de novo kidney transplants will run in parallel with LCP’s currently ongoing Phase III studies in stable kidney transplant patients.
Jim New, president and CEO of LCP, said: These results provide a very important milestone for LCP’s development activities in the Transplantation therapeutic area. The unique potential benefits of LCP’s MeltDose formulation technology as applied to LCP-Tacro are clearly highlighted in the safety, efficacy, and controlled-release properties of this product. It’s also an important step forward for our transplantation franchise and our plan to commercialize LCP-Tacro within the US and European pharmaceutical markets.