July 9 2008 | Category: Product
Bunnik, The Netherlands, 9 July 2008. AM-Pharma B.V., the biopharmaceutical company developing improved endogenous proteins and peptides against inflammatory and infectious disease, today announced the start of a second Phase II trial of bovine derived Alkaline Phosphatase to treat Acute Renal Failure. The trial will be double blind placebo controlled and will include 26 patients.
This second Phase II trial is expected to confirm and strengthen the results of an earlier exploratory trial with Alkaline Phosphatase in Acute Renal Failure, which was announced in March 2007. At that time AM-Pharma showed a strongly reduced need for dialysis and increased survival after treatment in a double blind placebo controlled Phase II trial in 16 Acute Renal Failure patients,
The trial will be managed by AM-Pharma’s own clinical team and will be conducted at the critical care units of Nijmegen University hospital and Isala hospital in Zwolle, The Netherlands.
Bart Wuurman, CEO commented: “The very encouraging results in patients with Acute Renal Failure in our first exploratory Phase II trial motivate the start of this second trial, which is designed to show a statistically significant reduction in serum creatinine levels and a reduced need for dialysis. We are very excited by the potential of our product in Acute Renal Failure, as it could become the first drug to be approved for this highly prevalent and often lethal medical condition.”
In May this year AM-Pharma announced the first tranche of a €20 million series C fundraising. Once the full C round has been closed, AM-Pharma will make a switch from bovine Alkaline Phosphatase to a recombinant form of enhanced human Alkaline Phosphatase. This switch to the medically and commercially more attractive recombinant material is justified by the positive results of the first trial in Acute Renal Failure and by the positive results of another Phase II trial with Alkaline Phosphatase in Ulcerative Colitis. Recombinant material will be used in all future trials.