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Kamada reports excellent intermediate results of phase I clinical trials of aerosolized AAT for the treatment of lung diseases31 May 2007 -
Kamada, a biopharmaceutical company which develops, manufactures and markets life-saving medicines, has successfully concluded the first of two stages of the phase 1 clinical study designed to test the safety of the aerosolized version of its flagship product, Alpha-1 Antitrypsin (AAT) using an optimized eFlow Electronic Nebulizer (PARI Pharma GmbH).
The study, which was executed according to a program approved by the European Medicines Agency (EMEA), involved 24 participants who received various doses of the inhaled drug. All dosage levels resulted in good safety profiles and tolerability, paving the way for continued clinical development of inhaled AAT using eFlow. According to David Tsur, Kamada's CEO, the encouraging results will enable the completion of the first phase of aerosolized AAT's clinical trials. "Kamada is progressing towards registration of both its intravenous and aerosolized AAT formulations in the European and American markets," says Tsur. "The intravenous version is currently undergoing Phase III trials in the U.S and we also intend to request FDA approval to test the aerosolized formulation." AAT [also known as API - Alpha-1 Proteinase Inhibitor] is used to treat Congenital Emphysema, caused by an inborn deficiency of Alpha-1 protein. The disease affects 1:2500 of the world's population, causing deterioration of lung tissue, severe respiratory disorders and eventually death.
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