Navigation Links
Cystic Fibrosis Axentis Pharma Initiates Clinical Trial for Lung Infections

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. However, we are already in a position to initiate clinical trials to fully assess its safety and tolerability and gather information on appropriate doses. I am very pleased for patients suffering from cystic fibrosis, who will benefit directly from this promising once-a-day treatment: a significant improvement both in treatment and patient management. This is also great news for our investors, who have helped us to advance so far in a very short time."

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

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

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

Dr. Schreier on the latest additions to the team: "Axentis Pharma is very happy to have such outstanding experts on its Scientific Advisory Board. Just as our investors provide us with the trust and financial means that are essential to the ongoing development of our products, Prof. Aguzzi and Prof. Lukacs will contribute to the intellectual capital of Axentis Pharma."

About cystic fibrosis

Cystic fibrosis is the most common life-threatening hereditary disease amongst Caucasian populations. The disease is caused by a mutation in the CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) gene found on chromosome 7. This mutation causes increased secretion deposits on mucous membranes. Lung complications represent the most serious manifestation of the disease ­ and the reason for the high mortality rate amongst patients. Such complications often involve infection of the bronchi by the bacteria Pseudomonas aeruginosa. Chronic inflammations then cause lung functions to become blocked. Besides the break-down of lung tissue, this also leads to bronchiectasis and lung failure.

About Axentis Pharma AG (

Axentis Pharma AG is a Swiss biotechnology company. The company is using a patent-pending platform technology to develop therapies for diseases caused by incorrect protein folding in the endoplasmic reticulum. The most prominent example of such diseases is cystic fibrosis (mucoviscidosis).

About Fluidosome(R) technology

Axentis Pharma's Fluidosome(R) technology uses biocompatible lipids endogenous to the lung that are formulated into small liposomes. This nanocapsules platform opens broad applicability for unmet medical needs including other respiratory diseases. In the case of the Fluidosome tobramycin(R), the interaction between tobramycin and the microbial cell is triggered when the liposomes attach to the outer cell membrane. Tobramycin then leaches into the inner cell compartment, which leads to rapid cell death.

For further information, please contact:

Axentis Pharma AG,

Brandschenkestrasse 60,


CH-8027 Zurich, T

+43-1-505-70-44 (PR&D),


Copy Editing & Distribution:

PR&D - Public Relations for Research & Education,

Campus Vienna Biocenter 2,

1030 Vienna, Austria,

T +43-1-505-70-44,


SOURCE Axentis Pharma AG
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Promising Cystic Fibrosis Compound on Track for Development
2. Symbollon Pharmaceuticals, Inc. Evaluates the Clinical Effects of IoGen(TM) on Fibrocystic Breast Disease
3. Pediatric Pulmonary Expert Comments on Study of Lung Transplants for Cystic Fibrosis
4. Cystic Fibrosis Foundation Reports Upward Trend for Key Health Outcomes
5. Cystic Fibrosis Foundation Announces Positive Early Results for Phase 2 Clinical Trial of VX-770 - an Oral Compound to Treat CF
6. Lung Transplants in Cystic Fibrosis Patients With Life-Threatening Bacteria Sparks Debate at ISHLT Meeting
7. PTC Therapeutics Announces Data Supporting Cough Frequency as a New Outcome Measure in Evaluating Treatments for Cystic Fibrosis
8. PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity
9. Transave Announces Positive Phase II Results for Once-Daily Arikace(TM) in the Treatment of Cystic Fibrosis Patients Who Have Pseudomonas Lung Infections
10. Mpex Initiates a Phase 2 Clinical Trial of Aerosol MP-376 in the Treatment of Chronic Bacterial Infections in Cystic Fibrosis Patients
11. The Ocean Becomes a Pipeline To A Cure for Cystic Fibrosis
Post Your Comments:
(Date:10/13/2015)... , Oct. 13, 2015  Data Science Automation (DSA), ... opening of a new branch office in the ... DSA,s presence in Europe . The decision ... increasing demand for local support of customers in the medical ... Ph.D., DSA,s UK Branch Manager. "We have had tremendous success ...
(Date:10/13/2015)... -- SeraCare Life Sciences, a leading partner to global in ... medicine business unit has launched its second product in ... (NGS)-based tumor profiling assays.  The Seraseq TM Solid ... mutations in key oncogenes and tumor suppressor genes as ... is offered at five additional allele frequencies. ...
(Date:10/13/2015)... , Oct. 13, 2015  Graduate students across ... and medical research, will soon have the opportunity ... care – the drug discovery and development process. ... has collaborated with 10 leaders from academic institutions ... Medicines: The Process of Drug Development."  Lilly will ...
Breaking Medicine Technology:
(Date:10/13/2015)... ... , ... Symposium Chairman, Dr. Rod J. Rohrich is pleased to announce that ... March 2nd and 3rd, 2016. The annual meeting, along with the Dallas Rhinoplasty ... around the world. , Key topics at this year's event will include discussions on ...
(Date:10/13/2015)... ... October 13, 2015 , ... Relay (, a ... announced today a significant contract that will provide its award-winning private messaging solution ... on the growing success of its Relay program, IBX Wire™, which now has ...
(Date:10/13/2015)... ... October 13, 2015 , ... NavaFit Inc. today announced the launch of ... train with, participate in local fitness & sporting events, and stay motivated. ... high medical costs drive us to get more serious about fitness and wellness, individuals ...
(Date:10/13/2015)... Boston, MA (PRWEB) , ... October 13, 2015 , ... ... mortar of the body, including muscle, bone, and blood. But how much protein does ... more complicated than it might seem, according to the October 2015 issue of ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... Scientists in ... tissue biopsy in 18 patients with or without mesothelioma. Surviving Mesothelioma has just posted ... , The doctors from PhenoPath Laboratories in Seattle and the University of British Columbia ...
Breaking Medicine News(10 mins):