Kamada Presents New Data on its Alpha-1 Antitrypsin at the American Thoracic Society Annual Meeting
“The results presented at ATS demonstrate the efficacy and safety of our intravenous and inhaled versions of alpha-1 antitrypsin in respiratory disease,” said David Tsur, Chief Executive Officer of Kamada. “Pending regulatory processes, we hope to have our intravenous product in the US market during the course of next year. We are also very excited about the prospects for our inhaled version of alpha-1 antitrypsin in cystic fibrosis, and other respiratory disorders, and look forward to continuing its development.”
Pivotal Phase II/III Study in AAT Deficiency
Robert Sandhaus, Professor of Medicine, Director Alpha-1 Program, National Jewish Health, Denver Co. presented final data from Kamada's pivotal study, a randomized, double blind, partial cross over study that explored Kamada's proprietary, liquid, ready to use, intravenous AAT (“Kamada-AAT”) in patients with AAT deficiency. Forty-nine patients were randomised 2:1 to receive 60mg/kg Kamada-AAT or an equivalent intravenous comparator product, on a weekly basis, for 12 weeks. After the first 12 week period all patients were dosed with Kamada-AAT for a further 12 weeks. The study was designed to show non-inferiority of Kamada-AAT to comparator AAT. The results of this study support the primary endpoint. Adverse events considered related to the study drug were similar to those reported for currently marketed AAT products.
Phase II Proof-of-Concept Study in Cystic Fibrosis
Eitan Kerem, Professor of Pediatrics, Hadassah Medical Center, Mt. Scopus, Jerusalem, presented final data from Kamada's Phase II, randomized, double blind, study that examined efficacy and safety of an inhaled version of Kamada's AAT (“Inhaled-AAT”) versus placebo. Twenty-one patients were randomized 2:1 to receive 80mg Inhaled-AAT or placebo, once-daily, for 28 days. The data showed 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 this study and the only adverse event reported, that was possibly related to study drug, was a sense of dry mouth (n=1). The results from this proof-of-concept study show that AAT administered via the inhaled route appears safe and biologically effective. Its impact on clinical endpoints, including measures of lung function, will be the subject of future studies.
Mark Brantly, Professor of Medicine, Molecular Genetics and Microbiology, University of Florida School of Medicine and Alpha One Foundation Research Professor, independently presented data at ATS in a poster entitled, “Intravenous Augmentation with Kamada API Binds to Free Lung NE in Alpha-1 Antitrypsin Deficient Individuals with Lung Disease”, which included an analysis of bronchoalveolar lavage (BAL) data from sixteen patients in the pivotal trial. Patients who received Kamada-AAT showed a >10 fold increase in AAT concentration in the epithelial lining fluid (“ELF”) after 12 weeks of augmentation therapy and a significant increase in AAT-neutrophil elastase complexes. These data confirm that Kamada-AAT reaches the lower respiratory tract and binds to free neutrophil elastase in the ELF.
About IV AAT
Kamada has developed a unique, high purity, liquid, ready-to-use human plasma derived AAT indicated for the treatment of Alpha 1 Deficiency. The product is produced using a sophisticated, chromatographic purification method.
About Inhaled AAT
Kamada's second generation AAT product to be administered via inhalation, is a high purity Alpha-1 Antitrypsin preparation that utilizes an optimized Investigational eFlow Nebulizer System (PARI Pharma GmbH). The product has been designated as an Orphan Drug for the treatment of Alpha-1 Deficiency, Bronchiectasis, and Cystic Fibrosis, in the U.S. as well as for Alpha-1 Deficiency and Cystic Fibrosis in Europe. This designation grants Kamada various benefits such as research fund support, tax incentives, reduced official fees and seven years of exclusive distribution rights, if the company's product is first on the market.
Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing and marketing a line of specialty life-saving biopharmaceuticals. Licensed and marketed worldwide, several of these specialty therapeutics are currently undergoing advanced clinical trials. Additional information is available at www.kamada.com.
Pnina Straus, +972 8-940 6472
Clinical Development and IP manager
Posted: May 2009