Cystic Fibrosis Axentis Pharma Initiates Clinical Trial for Lung ...( ZURICH Switzerland September 4 /-...),Health

ZURICH, Switzerland, September 4 /PRNewswire/ -- Axentis Pharma AG has initiated a clinical phase IIa trial to assess the safety and tolerability of a new therapeutic formulation for the treatment of severe pulmonary infection in cystic fibrosis patients. The new formulation allows an established therapeutic agent to be delivered directly to the site of infection. The forthcoming trial will also compare the effects of two different doses of the new drug. Initial results are expected in summer 2009. Axentis Pharma acquired all the necessary rights for this formulation from international partners just eight months ago. In addition to these advances, the company has also succeeded in appointing two renowned experts to its Scientific Advisory Board.

Axentis Pharma AG (Switzerland) announced today that all the necessary requirements for a clinical phase IIa trial have been fulfilled. The objective of this trial is to assess the safety and tolerability of an inhalable tobramycin, a well characterised and established drug for the treatment of pulmonary infection in cystic fibrosis patients. The product ARB-CF0223 ­ also known as Fluidosome(R) tobramycin ­ is a liposomal formulation of tobramycin, delivered directly to the site of infection via standard nebulizers. ARB-CF0223 has an improved safety profile and higher efficacy compared to current treatments for infections of the respiratory tract in patients with cystic fibrosis. It can be used in lower doses and also reduces the frequency and severity of side effects for pulmonary infections. The company expects to begin recruiting patients at its four international trial centres by the end of the year.

Dr. Hans Schreier, Chief Scientist of Axentis Pharma on the advances the company has made: "It was only very recently that we obtained all the necessary legal rights including transfer of sponsorship of the EMEA Orphan Designation to further develop our current lead product, Fluidosome(R) tobramycin. How
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