A new drug designed to prevent organ rejection in kidney transplant patients has shown positive results in trials, it has been announced.
LCP-Tacro, from Denmark-based drug firm LifeCycle Pharma (LCP), can be safely and effectively administered once daily to kidney transplant patients, results from a recent study show.
The company’s research compared LCP-Tacro tablets administered once a day with Prograf capsules administered twice daily in 63 transplant patients.
The findings are further supported by preliminary six-month follow-up data into the randomised transplant patients after they have moved into the one-year maintenance stage of the study.
Dr Jim New, president and chief executive 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 commercialise LCP-Tacro within the US and European pharmaceutical markets.”
LCP has now launched a pivotal Phase III study into the treatment and will consult with the US Food and Drug Administration in order to submit a final Phase III protocol in the second half of 2009.
Copyright Press Association 2009