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Cystic Fibrosis Axentis Pharma Initiates Clinical Trial for Lung Infections

Thursday, September 4, 2008 General News J E 4
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ZURICH, Switzerland, September 4 Axentis Pharma AG hasinitiated a clinical phase IIa trial to assess the safety and tolerability ofa new therapeutic formulation for the treatment of severe pulmonary infectionin cystic fibrosis patients. The new formulation allows an establishedtherapeutic agent to be delivered directly to the site of infection. Theforthcoming trial will also compare the effects of two different doses of thenew drug. Initial results are expected in summer 2009. Axentis Pharmaacquired all the necessary rights for this formulation from internationalpartners just eight months ago. In addition to these advances, the companyhas also succeeded in appointing two renowned experts to its ScientificAdvisory Board.

Axentis Pharma AG (Switzerland) announced today that all the necessaryrequirements for a clinical phase IIa trial have been fulfilled. Theobjective of this trial is to assess the safety and tolerability of aninhalable tobramycin, a well characterised and established drug for thetreatment of pulmonary infection in cystic fibrosis patients. The productARB-CF0223 ­ also known as Fluidosome(R) tobramycin ­ is a liposomalformulation of tobramycin, delivered directly to the site of infection viastandard nebulizers. ARB-CF0223 has an improved safety profile and higherefficacy compared to current treatments for infections of the respiratorytract in patients with cystic fibrosis. It can be used in lower doses andalso reduces the frequency and severity of side effects for pulmonaryinfections. The company expects to begin recruiting patients at its fourinternational trial centres by the end of the year.

Dr. Hans Schreier, Chief Scientist of Axentis Pharma on the advances thecompany has made: "It was only very recently that we obtained all thenecessary legal rights including transfer of sponsorship of the EMEA OrphanDesignation to further develop our current lead product, Fluidosome(R)tobramycin. However, we are already in a position to initiate clinical trialsto fully assess its safety and tolerability and gather information onappropriate doses. I am very pleased for patients suffering from cysticfibrosis, who will benefit directly from this promising once-a-day treatment:a significant improvement both in treatment and patient management. This isalso great news for our investors, who have helped us to advance so far in avery short time."

Fluidosome(R) technology is based on the well characterised drugtobramycin. Utilising synthetic liposomes containing tobramycin, a standardnebulizer delivers the drug directly to the endobronchial sites of infectionin cystic fibrosis patients. This results in prolonged, high local drugconcentration, which in turn achieves higher efficacy and enables lower doses.

The phase II study will be carried out in 4 international centres. Atotal of 24 patients will receive treatment: Eight will receive a twice-daily300 mg dose of the current tobramycin formulation over 28 days; another eightwill be given a twice-daily 150 mg dose of Fluidosome(R) over two weeks andlater a third group will receive one 300 mg dose of Fluidosome(R) per day fortwo weeks.

The company has also announced the appointment of two renowned experts toits Scientific Advisory Board. Prof. Adriano Aguzzi, Director of theInstitute of Neuropathology at University Hospital Zurich, Switzerland andProf. Gergely C. Lukacs, Canada Research Chair, Department of Physiology atMcGill University Montreal, Canada will in future advise Axentis Pharma onscientific and medical issues related to the company's product pipeline.

Dr. Schreier on the latest additions to the team: "Axentis Pharma is veryhappy to have such outstanding experts on its Scientific Advisory Board. Justas our investors provide us with the trust and financial means that areessential to the ongoing development of our products, Prof. Aguzzi and Prof.Lukacs will contri
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