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Axentis Pharma Initiates Phase IIa Cystic Fibrosis Trial

September 5, 2008

Axentis Pharma, a biotechnology company, 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 the summer of 2009.

According to Axentis Pharma, it has acquired all the necessary rights for this formulation from international partners eight months ago. In addition to these advances, the company has also appointed Adriano Aguzzi and Gergely Lukacs to its scientific advisory board.

Axentis Pharma has announced 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 characterized and established drug for the treatment of pulmonary infection in cystic fibrosis patients.

The product ARB-CF0223 A also known as Fluidosome tobramycin AӚ­ 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 centers by the end of 2008.

The Phase II study will be carried out in four international centers. A total of 24 patients will receive treatment: Eight will receive a twice-daily 300mg dose of the current tobramycin formulation over 28 days; another eight will be given a twice-daily 150mg dose of Fluidosome over two weeks and later a third group will receive one 300mg dose of Fluidosome per day for two weeks.




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