October 13, 2008
Kamada Presents Positive Data From Phase II Cystic Fibrosis Study
Kamada, a biopharmaceutical company, has reported positive data from its Phase II study evaluating inhaled Alpha-1 Antitrypsin delivered via an investigational eFlow Nebulizer System, in the treatment of cystic fibrosis.
The results demonstrate the product has an excellent safety profile and shows promising signs of efficacy, as indicated by a reduction in lung inflammation, the company said.
The Phase II trial was a double-blind, placebo-controlled study, performed at the Cystic Fibrosis Center at the Hadassah University Hospital, Mount Scopus Jerusalem, Israel, led by Eitan Kerem, head of the department of pediatrics.
The trial was designed to evaluate safety of the inhaled product in cystic fibrosis patients and to assess its potential efficacy in decreasing lung inflammation.
Study results revealed that daily inhalation of Alpha-1 Antitrypsin (AAT) for a period of 28 days reduced lung inflammation in comparison to placebo, as measured by neutrophil count and neutrophil elastase levels. There were no serious adverse events reported in either the active or the placebo group and no safety concerns were raised. In order to pursue clinical development of this product, Kamada will approach the regulatory authorities for guidance.
David Tsur, Kamada's CEO, said: "This is a breakthrough for Kamada. This product is the next generation of AAT treatment that may be used, subject to success of clinical trials and regulatory approval, as an effective treatment for cystic fibrosis patients, to improve their quality of life.
"We believe that the inhaled product will offer significant advantages to cystic fibrosis patients and we are very optimistic about its further development in this and in other respiratory patient populations."