Kamada Presents Data on Inhaled Alpha-1 Antitrypsin in Cystic Fibrosis Patients at the European Respiratory Society Meeting 2009, Vienna
NESS ZIONA, Israel--(BUSINESS WIRE)--Sep 14, 2009 - Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced that data on its next-generation alpha-1 antitrypsin (Inhaled-AAT) in cystic fibrosis patients was presented today, at the Annual Congress of the European Respiratory Society (ERS) 2009, Vienna. As previously reported, the study showed that inhaled-AAT was safe and biologically effective.
David Tsur, Chief Executive Officer of Kamada said, “We are delighted that Kamada was invited to present the results of its Phase II clinical study with inhaled-AAT at the European Respiratory Society meeting at a session focused on novel therapies for cystic fibrosis”. David Tsur continued, “We believe this demonstrates the excitement around our inhaled version of AAT within the field of respiratory medicine. Our product could have a significant impact on the lives of patients with cystic fibrosis and we look forward to advancing it into further clinical trials in the future”.
About the Study
The Phase II trial was a randomized, double blind, study that examined efficacy and safety of Kamada's inhaled-AAT versus placebo. Twenty-one patients were randomized 2:1 to receive 80mg Inhaled-AAT or placebo, once-daily, for up to 28 days. The data showed encouraging efficacy, as measured by a reduction in sputum neutrophil elastase and neutrophil count in patients treated with Inhaled-AAT. There were no serious adverse events reported in the study and the only adverse event, possibly related to study drug, was dry mouth (n=1). The results from this proof-of-concept study demonstrate that AAT administered via the inhaled route appears safe and biologically effective.
About Inhaled AAT
Kamada's Inhaled AAT is a high purity, liquid formulation of alpha-1 antitrypsin, manufactured using Kamada's proprietary chromatographic purification technology, that is delivered via an optimized Investigational eFlow Nebulizer System (PARI Pharma GmbH). Kamada has successfully completed two Phase II clinical trials in cystic fibrosis and bronchiectasis and further studies in these patients, and in patients with alpha-1 deficiency, are planned. The product has been designated Orphan Drug status for the treatment of, alpha-1 deficiency and cystic fibrosis, in Europe and for bronchiectasis, ha-1 deficiency and cystic fibrosis in the U.S.
Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing and marketing a line of specialty, life-saving therapeutics using a sophisticated chromatographic purification technology. Utilizing its proprietary know-how, Kamada manufactures more than 10 high quality biopharmaceuticals which are marketed in over 15 countries around the world. Kamada also has a number of products in development and has recently completed six clinical trials for its high-purity, liquid formulation of alpha-1 antitrypsin which is suitable for inhalation and intravenous use. Additional information is available at www.kamada.com.
Pnina Strauss, +972 8-940 6472
Clinical Development and IP manager
Posted: September 2009