Feb 14 2011
Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it received the interim report of its phase 2-3 trial to treat Alpha-1 deficiency with its flag product, Alpha-Antitrypsin, delivered by inhalation.
The report, which includes information on 13 months treatment of dozens of patients, shows an excellent safety and tolerability profile. The report adds significant further information to the safety profile of Kamada's inhaled Alpha-1 Antitrypsin that has already been established in five previous clinical trials, successfully completed by the Company.
The current Phase 2-3 trial is the most advanced stage a company has ever reached with inhaled AAT. The trial is performed at several sites in Europe, including Germany, the United Kingdom, the Netherlands, Denmark, Ireland and Scotland. The report allows Kamada to use the data collected in additional regulatory submissions and provides physicians and regulatory authorities additional confidence in the Kamada drug.
David Tsur, Chief Executive Officer of Kamada said, "We are proud of the results of the interim report and the completion of another important stage in this important development. Kamada aims to be the world's leader and the first company to introduce an inhaled Alpha-1 treatment. These results are encouraging not only to the Alpha-1 patients but also to other patients who suffer from chronic respiratory diseases such as Cystic Fibrosis, Bronchiectasis and COPD and for whom AAT by inhalation could be a treatment option."