Kamada Presents Data on Inhaled Alpha-1 Antitrypsin in Cystic Fibrosis Patients at the European Respiratory Society Meeting 2009, Vienna
Mon Sep 14, 2009 9:00am EDT
NESS ZIONA, Israel--(Business Wire)--
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.
About Kamada
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.
