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:12/2/2016)... British Columbia , December 2, 2016 - bioLytical lanza ... las nuevas directrices de la OMS     Continue Reading ... ... , , ... de enfermedades infecciosas, ha anunciado hoy que está expandiendo el lanzamiento de su ...
(Date:12/2/2016)... , December 2, 2016 Persistence ... pacemaker market in its upcoming report titled, "Global Market Study on ... Declining CAGR of -1.4% between 2016 and 2024". The global ... in 2015 and this is likely to decline to ... the global cardiac pacemaker market is anticipated to exhibit ...
(Date:12/2/2016)... , Dec. 2, 2016  LifeVac, the revolutionary device ... in the Emergency Response Training and Support Services (ERTSS) ... to have LifeVac become part of the ERTSS mission ... and CEO of LifeVac. "Having an established network of ... effectively will help leverage our efforts to spread LifeVac,s ...
Breaking Medicine Technology:
(Date:12/2/2016)... New York, NY (PRWEB) , ... December 02, 2016 , ... ... Through an exclusive interview with Mediaplanet, Dr. Murthy explains how he was inspired to ... “Early on I learned that medicine is about more than making diagnoses and prescribing ...
(Date:12/2/2016)... ... 02, 2016 , ... Mediaplanet is proud to announce the ... the innovative treatments, therapeutic technologies, and revolutionized nutrition that are helping patients and ... 6 years in the last 3 decades,” says Dr. Valentine Fuster, a world-renowned ...
(Date:12/2/2016)... ... , ... Rijuven Corp launches rejiva ( http://www.rejiva.com ), a unique wearable technology ... health technology on the market can deliver all that rejiva can. , “Rejiva promotes ... their health than the usual heart rate and steps taken”, adds Evens Augustin, CEO ...
(Date:12/2/2016)... ... December 02, 2016 , ... Today CloudMine, a secure, cloud-based ... named the best Sales Team of 2016 as part of the 2016 SIIA ... the Software & Information Industry Association (SIIA), the principal trade association for the ...
(Date:11/30/2016)... ... 2016 , ... "I hate when the mixture of saliva and toothpaste runs ... inventor from Bridgewater, N.J. "I thought that there had to be a way to ... the patent-pending DEFLECTOR to prevent saliva and toothpaste from running down the brush handle ...
Breaking Medicine News(10 mins):