AM-Pharma announces positive results of a Phase IIa clinical trial with Alkaline Phosphatase in Acute Kidney Injury

March 14 2007 | Category: Product

Bunnik, The Netherlands, 12 March, 2007. AM-Pharma B.V., the biopharmaceutical company developing novel therapeutics to treat infectious and inflammatory diseases, today announced positive results in patients with Acute Renal Failure. The patients involved were a subgroup of a Phase IIa trial with Alkaline Phosphatase to treat Sepsis.

Plasma creatinine clearance, a marker for renal function, improved by 45% (median) in patients with Acute Renal Failure treated with Alkaline Phosphatase and deteriorated by 25% (median) in patients with Acute Renal Failure treated with placebo, with p values of < 0.05.

In addition, the level of glutathione-S-transferase-A1, a marker for kidney damage, decreased by 70% (median) in AP treated patients, compared to a 200% (median) increase in placebo treated patients, with p values again of < 0.05.

Fifteen patients (10 active, 5 placebo) with Acute Renal Failure were treated for 24 hours as part of a double-blind, randomized, placebo-controlled Phase IIa study in 36 Sepsis patients. The study took place in the Department of Intensive Care Medicine at the Radboud University Medical Centre, Nijmegen, The Netherlands.

Bart Wuurman, CEO of AM-Pharma commented on the positive results, saying: “We are very excited by the results in this Acute Renal Failure subgroup. It shows statistically significant and clinically relevant improvements in a condition that is very difficult to treat, has a high mortality rate and is associated with high costs through long term dialysis treatment. We now plan to explore the use of Alkaline Phosphatase in Acute Renal Failure in a separate study.”


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