Navigation Links
Cystic Fibrosis - Orphan Drug Designation for Innovative Treatment Against Lung Infections by Axentis Pharma AG
Date:4/30/2009

ZURICH, Switzerland, April 30 /PRNewswire/ -- An innovative treatment for infections of the respiratory tract in cystic fibrosis patients has received orphan drug designation in the US. Axentis Pharma of Zurich, Switzerland announced today that this sought-after designation has been granted to its product candidate Fluidosomes-tobramycin, a therapeutic that will soon be tested in Phase II clinical trials. The company has now been granted orphan drug designation for this candidate in both Europe and the US.

Axentis Pharma (Switzerland) announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted the orphan drug designation to its lead product candidate Fluidosomes-tobramycin. This drug is a liposomal formulation of tobramycin, an innovative treatment for infections of the respiratory tract in patients with cystic fibrosis that is delivered directly to the site of infection via standard nebulizers. Pre-clinical and Phase I clinical studies support improved safety and efficacy profiles for Fluidosomes-tobramycin as compared to currently marketed treatments for infections of the respiratory tract in patients with cystic fibrosis.

The orphan drug designation is granted with respect to treatment of pulmonary infections caused by Pseudomonas aeruginosa, a bacterium that is one of the most common causes of infections of the respiratory tract in patients with cystic fibrosis. Axentis Pharmas product candidate received the orphan drug designation for the US only two months after the application and less than one year after orphan designation in Europe was transferred to the company. Dr. Helmut Brunar, company CEO and President, comments: "The orphan drug designation for the US is very good news for affected patients as well as for Axentis Pharma's shareholders. Together with the Orphan Drug Designation that was already achieved last year in Europe, the US Designation puts Axentis Pharma in a favourable position to register Fluidosomes-tobramycin in two major world markets with substantial support of the relevant authorities and at a cost advantage for the company. As a result, we will be able to deliver the product at competitive prices to patients once it has passed the final clinical test phase. In addition to this, the orphan drug designation grants Axentis several years of exclusive marketing rights once the product has been launched. That is a significant strengthening of Axentis Pharma market position as well as the company's value."

Fluidosomes-tobramycin combines the companys proprietary Fluidosomes technology with the well-established generic 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 may result in prolonged high local drug concentration in the lung, which in turn may lead to higher efficacy and may allow lower doses.

Currently, the company is initiating Phase II clinical trials that will assess the safety and tolerability of a new therapeutic formulation as well as the effects of two different doses of the new drug. Results of the clinical trial are expected early 2010.

About Axentis Pharma AG (http://www.axentispharma.com)

Axentis Pharma is a respiratory specialty pharmaceutical company which core competence is the application of a fully patented, encapsulating drug delivery system to already established and well-characterized therapeutic agents. Currently, the company is using this technology, named Fluidosome(R) technology, for the development of its lead product, a clinical stage treatment against cystic fibrosis (CF).

About Fluidosome technology

Axentis Pharmas Fluidosome technology uses biocompatible lipids endogenous to the lung that are formulated into small liposomes. This nanocapsule platform offers wide-ranging potential for unmet medical needs, including other respiratory diseases. In the case of Fluidosome-tobramycin, 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.

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 cystic fibrosis transmembrane conductance regulator (CFTR) 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. As well as the breakdown of lung tissue, this also leads to bronchiectasis and lung failure.

    For further information, please contact:

    Dr. Helmut Brunar, Ph.D.,
    CEO Axentis Pharma AG
    Limmatquai 138 CH-8001
    Zurich, Switzerland,
    T +41-44-202-7878,
    E board@axentispharma.com,
    Whttp://www.axentispharma.com

    Copy Editing Distribution:
    PR - Public Relations for Research Education
    Campus Vienna Biocenter 2 1030 Vienna
    Austria,
    T +43-1-505-70-44,
    E contact@prd.at,
    Whttp://www.prd.at


'/>"/>
SOURCE Axentis Pharma AG
Copyright©2009 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:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, ... Board will take whatever measures required to build a ... stock which is currently listed on the OTC Markets-pink ... Company Chairman and CEO, "We are seeing an anomaly ... to understand, not only by the Company, but shareholders ...
(Date:6/24/2016)... N.J. , June 24, 2016  Collagen ... the design, development and manufacturing of collagen and ... regeneration announced today that Bill Messer ... and Marketing to further leverage the growing portfolio ... medical devices. Bill joins the Collagen ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... and Markets has announced the addition of the ... their offering. ... products and provides an updated review, including its applications ... covering the total market, which includes three main industries: ...
Breaking Medicine Technology:
(Date:6/27/2016)... Brooklyn, NY (PRWEB) , ... June 27, 2016 ... ... is using cutting edge technology to revolutionize the emergency ambulance transport experience for ... Many are aware of how Uber has disrupted the taxi industry through the ...
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating ... many ways they remain in the eye of the beholder, according to experts who ... of The American Journal of Managed Care. For the full issue, click here ...
(Date:6/26/2016)... Viejo, California (PRWEB) , ... June 26, 2016 , ... ... Final Cut Pro X. , "Film editors can give their videos a whole new ... said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels contains ...
(Date:6/26/2016)... ... ... a legally blind and certified personal trainer is helping to develop a weight loss fitness ... to fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
Breaking Medicine News(10 mins):