October 6 2006 | Category: Product
Bunnik, the Netherlands, October 20, 2006. AM-Pharma B.V., a biopharmaceutical company engaged in the pre-clinical and early clinical development of novel compounds to treat infectious and inflammatory diseases, announces first positive results observed in its multi-center double blind, placebo-controlled pilot study in the treatment of sepsis with its patented Alkaline Phosphatase (AP) drug. The study was conceived as a first pilot clinical study to assess safety of a single treatment with 200 U Alkaline Phosphatase i.v./kg in patients suffering from severe sepsis. At the same time also efficacy parameters were recorded as secondary variables.
AM-Pharma is developing a unique therapy against sepsis, based on detoxification of the bacterial endotoxin LPS. This is an early mediator in the sepsis cascade, and one of the highest possible upstream targets, and therefore a promising approach for the development of a successful therapy.
Dr. Bruno Giannetti, President & Chief Executive of AM-Pharma: “These are very promising data, although obtained in relatively small patient numbers, particularly when considering the fact that the dose and the treatment schedule still needs to be optimized. We are now in the process of planning a dose finding pivotal trial to optimize the dosing regime and demonstrate the efficacy of the drug.”
A total of 36 patients admitted to intensive care units with the diagnosis of severe sepsis were included in the study (25 Verum/11 Placebo, 2:1 randomization scheme). The treatment consisted in a bolus of 67.5 U/ kg infused in the first 10 minutes followed by a 23 hour and 50 minutes infusion of a total of 132.5 U/kg. The primary aim of the study was to assess safety of the treatment. Next to (serious) adverse events (S)AEs also 28 and 90 days survival rates were recorded.
The treatment was well tolerated. No drug-related SAEs were reported in the Verum group. The 28 days survival rates were 19/25 in the Verum and 7/11 in the Placebo group. The 90 days survival rates were 18/25 in the Verum and 6/11 in the Placebo group. The reduction of the mortality risk due to sepsis is represented by the calculated absolute and relative risk reduction. After 28 days, the Verum group showed 12.4% absolute risk reduction and 34% relative risk reduction. After 90 days absolute risk reduction was 17.5% and relative risk reduction was 38.4%.