LifeCycle Pharma Announces Positive Interim Phase II Clinical Trial Results for LCP-Tacro, an Immunosuppressant for the Treatment of Kidney Transplant Patients
"We are pleased with the positive results of this interim data, which further supports LCP-Tacro's once-daily profile and increased bioavailability, said Dr. Flemming Ornskov, President and CEO of LifeCycle Pharma. "The continued growth of our organ transplantation franchise is integral to the success of our business strategy of evolving into a fully integrated specialty pharmaceutical company. LCP-Tacro (kidney) in Phase II and LCP-Tacro (liver) nearing Phase II, demonstrates the successful execution of our strategy" added Dr. Ornskov.
With the clinical trial data from a pre-planned 10 patient interim assessment, LCP's ongoing Phase II clinical trial remains on track to enroll an additional 40 patients, bringing the total number of targeted patients enrolled to 50, in up to 12 sites in the U.S. The Company expects that the Phase II clinical trial will provide a robust statistical assessment, confirm the proposed dosing regimen and support the initiation of a Phase III clinical trial in 2008 in de-novo kidney and stable kidney transplant recipients. Top-line results from the Phase II clinical trial are expected by year end 2007 or early 2008.
In addition, the interim Phase II data further supports the series of successful Phase I trials of LCP-Tacro, involving more than 150 healthy volunteers, that demonstrated that LCP-Tacro has a once daily profile and higher bioavailability of tacrolimus.
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) worldwide) and its modified-release version of tacrolimus for organ transplants, (Advagraf(R) in Europe). 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.
LCP-Tacro (Kidney) Phase II Clinical Trial Design
The Phase II clinical trial, which commenced enrollment in July 2007, is a three sequence, open-label, multi-center, prospective, conversion study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets Once-A-Day versus Prograf(R) (tacrolimus) capsules Twice-A-Day. Stable kidney transplant patients who fulfill all I/E (inclusion/exclusion) criteria are enrolled and kept on Prograf(R) for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for Prograf(R), all patients are converted to once daily LCP-Tacro for 7 days with no dose changes allowed. On Day 14 and Day 21, a 24-hour LCP-Tacro PK study will be performed. On Day 22, patients will be converted back to their original twice daily dose of Prograf(R) for a safety follow-up period of 30 days ending with a safety assessment on day 52.
About Immunosuppression Therapy and Kidney Transplantation
In order to prevent the patient's immune system from rejecting the transplanted organ, immunosuppression therapy 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 immunosuppressants used in transplantation in the 7 major markets is approximately $3.3bn and is estimated to grow by approximately 5-10% per year.
Kidney transplantation is normally recommended for patients with end-stage kidney disease or kidney failure caused by severe, uncontrolled hypertension, diabetes, infections, intoxication, or inflammation. Kidney transplants account for approximately 60% of all transplants performed annually in the seven major markets, and kidney transplants generally offer the best outlook for patients with end-stage kidney disease. Most centers have patient and organ survivals of over 90% at one year, and more than 80% at three years. Approximately 50% of transplanted kidneys are still functional after 10 to 15 years.
About LifeCycle Pharma A/S ("LCP")
LCP, headquartered in Horsholm, Denmark, is an emerging specialty pharmaceutical company focused on developing and commercializing a portfolio of innovative products in therapeutic areas such as cholesterol management, hypertension, organ transplantation and autoimmune diseases. LCP's proprietary MeltDose(R) technology, offers lower dosing, reduced side effects, improved safety and patient compliance, and reduced product development costs and times. LCP-FenoChol, a fenofibrate for the treatment of hyperlipidemia and hypertriglyceridemia, is LCP's first FDA approved product (approved in August 2007). LCP is listed on the OMX Nordic Exchange under the trading symbol (OMX:LCP). For further information, please visit www.lcpharma.com.
LifeCycle Pharma A/S
Michael Wolff Jensen, +45 4074-6244
Executive VP & CFO
Francesca M. DeMartino, 201-633-4729
Director, Investor Relations & Corporate Communications
Posted: October 2007