BASINGSTOKE, England, October 31 /PRNewswire/ -- Shire today announced the start of a new Phase IIIb clinical trial to evaluate two new dosing schedules of DYNEPO(R) (epoetin delta), the first commercial erythropoiesis-stimulating agent produced in a human cell line. DYNEPO is used in the treatment of anaemia in patients with chronic kidney disease (CKD[i]). Anaemia becomes more common and severe as a patient's kidney function declines.(1)
Patients with anaemia have reduced haemoglobin levels. DYNEPO has previously been shown to be as effective as epoetin alfa in increasing and then maintaining haemoglobin levels in the target range (10-12 g/dL) in patients with anaemia associated with CKD when initially given three times per week by the intravenous route.(2,3) It is also effective when given twice per week via the subcutaneous route.(3,4) This open-label, randomised study will investigate the efficacy and safety profiles of different starting doses of DYNEPO administered by subcutaneous injection, which are at a lower frequency (once weekly and once every two weeks) than those currently approved for subcutaneous administration.
The study is planned to enrol over 400 patients with anaemia and CKD, who are either not on dialysis, who require peritoneal dialysis or who require haemodialysis, at over 50 centres across Europe. It will include patients suffering from kidney disease as a result of diabetes (diabetic nephropathy).
The primary endpoints of the study are to:
-- assess whether DYNEPO administered once per week is as effective as when administered twice per week for patients who have not previously been treated with an erythropoiesis-stimulating agent (this will be assessed by measuring haemoglobin levels at Week 24).
-- assess whether DYNEPO administered once every two weeks is as effective as when administered once per week for patients who have been previously treated with another erythropoiesis-stimulating agent (this will be assessed by measuring haemoglobin levels over Weeks 16 to 24).
Dr Iain Macdougall, lead investigator of the study and Consultant Nephrologist and Honorary Senior Lecturer from the Renal Unit in King's College Hospital, London commented, "If the study demonstrates the efficacy of the different dosing schedules of DYNEPO, it will allow future flexibility in the frequency of subcutaneous administration of the product. An interesting secondary endpoint of this study is to also monitor diabetic retinopathy, the progressive damage to the eye's retina, in those patients with anaemia, diabetes and CKD."
CKD is a progressive condition that results in end stage renal disease (ESRD). Approximately 1.8 million people worldwide are undergoing treatment for ESRD, of whom approximately 77% are on dialysis.(5) In Europe, the prevalence of ESRD is estimated at 225,000, growing at 6 per cent per annum.(6)
"This new trial demonstrates Shire's continuing commitment to the care of people suffering from CKD and ESRD," commented David Milton, Senior Vice President, Renal Business Unit Leader, Shire.
ABOUT DYNEPO
Erythropoietin is normally produced in the kidneys and stimulates the bone marrow to produce more red blood cells by promoting the development of stem cells into mature red blood cells. Red blood cells (erythrocytes) contain haemoglobin and are vital for oxygen transportation around the body. If the kidney starts to fail, natural production of erythropoietin declines leading to lower levels of haemoglobin (anaemia). DYNEPO is the first erythropoiesis-stimulating agent produced by gene-activation technology in a human cell line; all others are produced in animal cell lines - either Chinese Hamster Ovary Cells or baby hamster kidney cells. Anaemic patients with CKD require treatment with an erythropoiesis-stimulating agent such as DYNEPO in order to increase red blood cell production. Currently DYNEPO is given twice weekly if administered via the subcutaneous route, and three times per week if administered intravenously.
Notes to Editors
SHIRE PLC
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing and merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: www.shire.com.
References
1. Locatelli F, Alijama P, Barany P et al. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. Section 1: Anaemia evaluation. Nephrol Dial Transplant 2004a; 19 Suppl 2: ii2-ii5.
2. M Smyth, KJ Martin, RP Pratt. Epoetin delta (Dynepo(R)), erythropoietin produced by a human cell line, is as effective as epoetin alfa in patients with renal anaemia, including those with diabetic nephropathy. Poster presented at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD), 14-17 September 2006, Copenhagen-Malmoe, Denmark-Sweden.
3. DYNEPO Summary of Product Characteristics (SPC). 8 June 2006. Shire plc. Available at URL: http://www.emea.eu.int/humandocs/PDFs/EPAR/dynepo/H-372-PI-e....
4. JTC Kwan, M Smyth, RD Pratt. Human cell line derived erythropoietin (epoetin delta, Dynepo(R)) administered subcutaneously is effective in the management of anaemia associated with chronic kidney disease. Poster presented at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD), 14-17 September 2006, Copenhagen-Malmoe, Denmark-Sweden.
5. Grassmann A, Gioberge S, et al. ESRD patients in 2004: global overview of patient numbers, treatment modalities and associated trends. Nephrol Dial Transplant 2005; 20: 2587-2593.
6. Molowa DT. First annual nephrology survey. With a focus on Aranesp and Renagel. J.P.Morgan Securities Inc. Equity Research. 13 February 2002. ---------------------------------
[i] CKD is sometimes referred to as chronic renal failure
For further information please contact: Media Shire, Jessica Mann, +44-1256-894-280; Media PR agents for DYNEPO, Resolute Communications, Claire Woods , +44-207-357-8187; Media PR agents for DYNEPO , Resolute Communications, Marilyn Ewan, +44-207-357-8187
