Nephoxil is an investigational new drug for the treatment of hyperphosphatemia in ESRD patients. A Phase II, multi-centre, randomised, double-blind, placebo-controlled, dose-ranging clinical trial was completed showing that Nephoxil was efficacious with acceptable tolerability. The positive Phase II clinical trial successfully demonstrated Nephoxil a promising treatment for hyperphosphatemia.
Hyperphosphatemia occurs in most ESRD patients. If not treated, the effects of hyperphosphatemia can be serious and result in bone disorder (renal osteodystrophy), heart disease and vascular calcification and increase the morbidity rate in ESRD patients. Twice or thrice weekly dialysis and diet restrictions are not sufficient to remove the dietary intake of phosphorous in the body and, thus, phosphate binders are required.
It is estimated that in 2004 there were approximately 1.4 million people worldwide receiving dialysis treatment for ESRD, with the number of patients growing at an annual global average rate of 7 per cent. In 2004, 492,000 US citizens were diagnosed with ESRD, representing a prevalence rate of 0.15 per cent, and approximately 261,000 Japanese citizens were diagnosed, representing a prevalence rate of 0.2 per cent. As a result of ageing populations and the global diabetes epidemic, the number of ESRD patients in the US is expected to double by the year 2010, according to the USRDS.
PB1612:
PB1612 is under development to combat soft tissue calcification in renal failure patients. In renal failure patients, calcification can cause a wide spectrum of clinical effects in arteries, in eye, around joints, in skin and subcutaneous tissues, and also in internal organs such as the lungs, kidney, stomach and heart.
It has been reported that cardiovascular disease, particularly coronary artery disease and chronic heart failure, substantially increases morbidity and mortality in ESRD patients. Chronic kidney disease patients have 2 to 5 times more coronary artery calcification than healthy age-matched individuals. In ESRD patients, it has been reported that on average of 83% of dialysis patients have some degree of coronary artery calcification. Vascular calcification is a strong prognostic marker of cardiovascular disease mortality in CKD patients. The USRDS has reported cardiac causes of death account for approximately 50 per cent of all deaths of ESRD patients.
PB1603:
PB1603 will soon be under development to combat Chronic Kidney Disease (ˇ§CKDˇ¨). CKD is a gradual and progressive loss of the ability of the kidneys to excrete wastes, concentrate urine, and conserve electrolytes. Unlike acute kidney failure with its abrupt but reversible of kidney function, the kidney function in CKD progresses irreversibly and slowly gets worse toward end stage renal disease (ESRD). Patients suffering from ESRD can not survive without dialysis or kidney transplantation. CKD usually occurs over a number of years as the internal structures of the kidney are damage.
It has been estimated by the US National Kidney Foundation that in excess of 20 million US citizens, representing approximately 11 per cent of the population, suffer from CKD with a further 20 million at increased risk. The high prevalence rate of CKD posed a significant burden on the healthcare system. It has been reported that by slowing down the progression rate of CKD by 30 % (as defined as decreasing the rate of decline in GFR by 30%) between 2000 and 2010, the estimated potential cumulative direct healthcare savings would be US$60.61 billion.
Prevalence rate and population at different stage of Chronic Kidney Disease (US)
