PHILADELPHIA, Nov. 12 /PRNewswire/ -- Roche’s innovative anti-anemia agent CERA (Continuous Erythropoietin Receptor Activator) was able to control anemia in patients with chronic kidney disease (CKD) not on dialysis within a narrow target range set out in expert guidelines for more than one year. The Phase II extension data presented for the first time at the American Society of Nephrology 38th Annual Meeting & Scientific Exposition - Renal Week meeting in Philadelphia today,(1) mirror those presented earlier this year in dialysis patients(2) suggesting that CERA provides consistent anti-anemia activity in a broad spectrum of patients with CKD. Phase II results with CERA are being confirmed in an extensive Phase III clinical program.
“CERA provided consistent and reliable hemoglobin levels in a controlled manner that resembles how the body naturally regulates itself,” said lead investigator Robert Provenzano, MD, St. John Hospital and Medical Center, Detroit, MI. “The current guidelines for anemia management(3), including those in the US(4), recommend that CKD patients be kept in an optimal range between 11 to 12 g/dL and CERA achieved this at extended dosing intervals. This is important news, as maintaining a patient in this range is difficult; recent reports(5) have pointed out that many patients’ hemoglobin levels fluctuate with excursions outside of this target range. CERA would be the first agent with demonstrated effectiveness at dosing intervals as long as three to four weeks. This is expected to substantially facilitate anemia management for physicians and patients, while allowing Hb levels to remain on target with fewer interventions.”
Anemia (inadequate hemoglobin - Hb) is a common comorbidity in CKD patients but is under-diagnosed and under-treated in the early, pre-dialysis stages of this progressive illness. The need to treat anemia in this patient population is gaining recognition as anemia has been linked to the development of cardiovascular disease and acceleration of the progression of kidney disease.(6)
Study Details
Following a 19-week multi-center Phase II study of subcutaneous CERA for the correction of anemia, 51 epoetin-naive patients with CKD not on dialysis continued to receive their original dose of CERA over a 54-week period. CERA was administered subcutaneously once weekly, once every two weeks or once every three weeks with the aim of maintaining Hb levels at 11-12 g/dL. During the study period, mean Hb levels, measured on a monthly basis, were 11.3 g/dL with once weekly use, 11.4 g/dL with once every two week use, and 11.7 g/dL with once every three week use.
Safety Information
In this study, CERA was generally well tolerated and the frequency of adverse events (AEs) appears to be characteristic of this patient population. The most frequently reported AEs were urinary tract infections, gout, hypertension, peripheral edema, and insomnia, which accounted for 5.44%, 3.41%, 3.03%, and 3.03% of all episodes, respectively.
About CERA
CERA is an innovative chemical entity being investigated for the treatment of anemia in chronic kidney disease and anemia associated with chemotherapy in cancer patients. CERA is an investigational anti-anemia agent which is believed to stimulate red blood cell production in a novel and continuous fashion. Roche has undertaken the largest phase II - III program ever for a drug treating renal anemia with 10 trials involving more than 2,700 patients with the aim to be able to provide a drug which can be given at extended dosing intervals while providing stable and sustained control of anemia. It is currently nearing completion of Phase III of its development in CKD and Roche aims to file CERA in the U.S. and worldwide in 2006.
About Anemia
Anemia affects up to 90 percent of patients with renal disease from patients with relatively early stage CKD to patients with kidney failure requiring dialysis. Anemia is a condition in which the hemoglobin level in the blood is reduced, either because the red cells containing hemoglobin are reduced in number or because the hemoglobin content in the red cells is abnormally low. Hemoglobin enables red blood cells to carry oxygen throughout the body and reduction in hemoglobin will reduce the oxygen carried to the cells unless the heart increases its output substantially. When the body is starved of the oxygen it requires, extreme fatigue sets in along with dizziness. The increased load on the heart can lead to heart failure and causes increased morbidity and mortality in patients with end-stage kidney disease.
Normally, when the body senses a decrease in red blood cells or a decrease in oxygen, more erythropoietin (a protein produced by the kidneys) is created. This protein stimulates the production of oxygen-carrying red blood cells in the bone marrow which raises the red blood cell count. When this natural mechanism is hindered (as in kidney disease patients), it is necessary to stimulate the receptors to produce red blood cells with agents such as CERA. CERA has different receptor binding characteristics and prolonged serum half- life.
About Roche - More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world’s leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.
Roche’s U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine’s list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche’s Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche’s Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: www.roche.com and U.S.: www.roche.us).
References 1. Provenzano R, et al. Subcutaneous CERA (Continuous Erythropoietin Receptor Activator) Maintains Hemoglobin levels with administration levels up to 3 weeks in Chronic Kidney disease patients not on dialysis. American Society of Nephrology, 2005. 2. Locatelli, Francesco et al. Subcutaneous CERA (Continuous Erythropoietin Receptor Activator) Maintains Hemoglobin Concentrations With Dosing Intervals Up To 4 Weeks In Dialysis Patients. ERA-EDTA 2005. 3. Revised European Best Practice Guidelines for the Management of Anemia in Patients with Chronic Renal Failure, Nephrol Dial Transplant (2004) 19 [Suppl 2]. 4. NKF K/DOQI Guidelines for Anemia of Chronic Kidney Disease 2000. 5. Fishbane S and Berns J. Hemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney International, Vol. 68 (2005), pp. 1337-1343 6. Rao M and Pereira B. Optimal anemia management reduces cardiovascular morbidity, mortality and costs in chronic kidney disease. Kidney International, Vol. 68 (2005): 1432-1438.
Roche
CONTACT: Shelley Rosenstock of Roche, +1-973-562-2373,shelley.rosenstock@roche.com; or Harriet Shelare of Manning Selvage & Lee,+1-212-468-3612, Cell, +1-917-653-9714, harriet.shelare@mslpr.com
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