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Dutch AM-Pharma announces positive results of Phase IIa trial 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.”
- ENDS -
Notes to editors:
About AM-Pharma 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.
*** Should you be interested in downloading a white paper on AM Pharma’s
Alkaline Phosphatase Phase IIa trial and its application in the treatment of
Acute Renal Failure, please click here –
www.am-pharma.com or contact Justine Lamond on +44 (0)20 7268 3242 or
j.lamond@northbankcommunications.com
For further information, please contact
Northbank Communications
Justine Lamond
Tel: +44 (0)20 7268 3242
j.lamond@northbankcommunications.com
AM Pharma
CEO Bart Wuurman
Tel: +31 (0)30 2289222
www.am-pharma.com
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