Oct 26 2008
Kamada has announced that it has completed the final analysis of its US Phase III trial with intravenous Alpha-1 Antitrypsin (AAT), for hereditary AAT deficiency.
In keeping with headline results announced in April, the study met its primary endpoint. The company has now officially completed the clinical stage of this product's development, high safety profile sided to meeting the primary endpoint were determined.
The company is pleased with the final outcome of this study and plans file a BLA with the FDA in 2009. Information about the study will be presented at an upcoming major medical conference.
The trial, conducted in accordance with FDA requirements, was a controlled, randomized, double-blind, partial cross-over study that compared Kamada’s intravenous AAT with a comparator product. Forty-Eight AAT-deficient patients were randomized 2:1 for the first 12-weeks to weekly infusion of Kamada’s AAT or weekly infusion of comparator drug; all patients then received Kamada’s AAT for a further 12 weeks. The efficacy endpoints of the study were determined by serum concentration of AAT and levels of AAT and other biomarkers in epithelial lung fluid. Safety parameters were explored and determined.
Key points: The results indicate the high quality of the Kamada product and its ability to reach the required trough levels in AAT patients. With regards to safety, no safety concerns were demonstrated. The safety profile was comparable to that of the comparator product.
David Tsur, Chief Executive Officer of Kamada, commented: "This is a major achievement for Kamada and it marks another significant step in our strategy to enter the US market with this product. Our intravenous AAT is the only ready-to-use AAT product that does not require reconstitution before use, offering patients and care-givers a much more convenient treatment option. Additionally, the high purity of the product and the fact that it does not consist of any added substances increases its future acceptance in the medical community."
http://www.kamada.com