AM-Pharma Announces Positive Results of a Phase IIa Clinical Trial with Alkaline Phosphatase in Acute Renal Failure
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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Notes to editors:
About AM-Pharma www.am-pharma.com http://www.am-pharma.com/> AM-Pharma is a biopharmaceutical company focused on the preclinical and clinical development of novel compounds in the field of severe infectious diseases and inflammatory diseases.
AM-Pharma is currently conducting Phase II clinical trials on two products:
* Alkaline Phosphatase for Sepsis, Acute Renal Failure and Ulcerative Colitis. * Anti-microbial Peptide hLF1-11,for the prevention of infections in Hemopoietic Stem Cell Transplant patients.
AM Pharma is based in Bunnik, The Netherlands with a staff of 20. The company is financed by, amongst others, Forbion Capital Partners and Inventages Venture Capital. Once product safety and efficacy have been established, AM-Pharma will look for world-wide development and marketing partners for its products.
About Acute Renal Failure Hospital-acquired Acute Renal Failure occurs in as many as 4% of hospital admissions and 20% of critical care admissions. The growing incidence of hospital-acquired Acute Renal Failure is due to an increasingly aging population, an increased probability of exposure to nephrotoxic drugs in hospitals and an increasing number of surgical interventions. Depending on the severity of renal failure, mortality rates can range from 7% to as high as 80%. Of patients that do survive, between 20% and 60 % require ongoing dialysis treatment.
Posted: March 2007