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Results expand potential application of key product in AM-Pharma's pipeline
BUNNIK, The Netherlands, 14 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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