Shire Pharmaceuticals reported new study results about Dynepo (epoetin delta), developed using innovative gene activation technology in a human cell line. The data show that epoetin delta corrects and maintains haemoglobin levels in patients suffering from anaemia and CKD who are on dialysis. The study results were presented at 11th Congress of the European Haematology Association (EHA).
A second study, also presented for the first time, highlighted a key difference between Dynepo and other erythropoietin treatments - an unquantifiably low amount of a specific carbohydrate residue compared to those treatments produced in Chinese Hamster Ovary cell lines. This carbohydrate residue is known to produce immune responses in humans. Potential differences in immunogenicity between Dynepo and other erythropoietin treatments have not been investigated in clinical practice.
Dr Iain Macdougall, Consultant Nephrologist and Honorary Senior Lecturer from the Renal Unit in King's College Hospital, London commented, "There is a pressing need for further research into the differences between Dynepo and conventional erythropoietin treatments that are not produced in human cell lines. It will be fascinating to see whether these differences will ultimately translate into specific benefits for patients with CKD who are suffering from anaemia."
By stimulating red blood cell production in the bone marrow, Dynepo performs the same role as naturally occurring human erythropoietin.
The prevalence of anaemia in patients with CKD rises as kidney function declines4 and in Europe, the prevalence of end stage renal disease is estimated at 225,000, growing at 6 per cent per annum, with more than 80 per cent of these patients on dialysis.5
Dr Raymond Pratt, Vice President Global Medical Affairs, Shire, added, "Shire is proud to be involved in products produced by this ground-breaking gene activation technology. We are committed to bringing innovative products, like Dynepo, to market to meet patients' needs. Dynepo will be another addition to our renal therapeutics area, focusing on patients with anaemia and CKD."
The primary cause of anaemia in CKD is a deficiency in erythropoietin, a protein produced by the kidneys responsible for red blood cell production.6 As renal function declines, so does the capacity for producing erythropoietin and consequently red blood cells. Additionally, anaemia in patients with CKD may be aggravated by a loss of red blood cells during haemodialysis. Consequences can be serious with increased risk of cardiovascular disease, the main cause of death amongst dialysis patients, along with a major impact on the quality of life through fatigue and a reduction in life-expectancy due to cardiovascular complications.
If the kidney starts to fail, patients require an increase in erythropoietin from a treatment such as Dynepo in order to increase red blood cell production. Red blood cells (erythrocytes) contain haemoglobin and are vital for oxygen transportation around the body. Erythropoietin is 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. These cells are then released into the blood stream. Dynepo works in exactly the same way.