Navigation Links
Savara Pharmaceuticals Completes Phase I Clinical Study of AeroVanc in Cystic Fibrosis Patients

AUSTIN, Texas, June 12, 2012 /PRNewswire/ -- Savara Pharmaceuticals, an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions, today announced positive top-line data from its AeroVanc Phase I clinical study in patients with cystic fibrosis (CF). 

AeroVanc, a dry powder formulation of vancomycin, is the first inhaled antibiotic being developed for the treatment of respiratory methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with CF.  The dose-escalating Phase I clinical study examined the tolerability, safety and pharmacokinetics of AeroVanc in non-MRSA infected CF patients. AeroVanc was well tolerated and safe and produced high concentrations of vancomycin in the sputum.  In line with the pharmacokinetic results in healthy volunteers, the clearance of vancomycin from the lungs was slow, indicating a favorable profile for once- or twice-daily dosing.

"Persistent MRSA lung infection in CF patients has been associated with faster decline of lung function and significantly shortened survival. Whereas inhaled antibiotics have become a cornerstone of treatment of Pseudomonas infections in CF, there are currently no approved inhaled drugs available to treat MRSA lung infection," said Elliott C Dasenbrook, Associate Director of the Adult Cystic Fibrosis Program at Case Western University.  "Pulmonary delivery of vancomycin is a very promising treatment concept to ensure high drug concentrations at the site of infection, while minimizing systemic toxicity and treatment burden."

"In this trial we have demonstrated sputum concentrations of vancomycin known to effectively kill MRSA, and we therefore have high confidence in being able to suppress or even eradicate the infection with AeroVanc in our Phase IIa study in MRSA-infected patients," said Robert Neville, Chief Executive Officer, Savara. 

Savara also recently announced a successful Series B fundraising of $8.6 million.  Proceeds from the financing will support AeroVanc's advancement through the Phase IIa clinical study, scheduled to start early next year.

About AeroVanc

AeroVanc (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration.  Vancomycin administered by IV is the antibiotic of choice for the treatment of MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting.  AeroVanc is the first inhaled antibiotic being developed for the treatment of MRSA infection in cystic fibrosis patients.  By delivering vancomycin directly to the site of infection, AeroVanc is expected to improve clinical efficacy and reduce adverse effects due to systemic drug exposure.

AeroVanc has demonstrated positive safety and tolerability results in a Phase I clinical study conducted in healthy subjects and patients with cystic fibrosis, with a pharmacokinetic profile that supports its potential as a once- or twice-daily treatment for pulmonary MRSA infections.

About Cystic Fibrosis and MRSA

Cystic fibrosis is a genetic disease characterized by the prevalence of thick, sticky mucus produced in the lung, frequent lung infections and a resultant decline in pulmonary function.  As the disease progresses, patients' lungs are typically colonized with bacteria that are difficult to eradicate. Such infections are typically treated with inhaled antibiotics, which have become one of the cornerstones in the treatment of cystic fibrosis over the last decade. In recent years, infection and colonization by MRSA has become increasingly common, with a prevalence of almost 30 percent of all cystic fibrosis patients in the United States.  Persistent MRSA infection has been found to cause a faster decline in lung function and to be associated with a significantly shortened life expectancy.  Currently there is no approved inhaled treatment for MRSA infection in cystic fibrosis patients. 

About Savara Pharmaceuticals

Savara Pharmaceuticals is an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions.  The company's lead product, AeroVanc (vancomycin hydrochloride inhalation powder), is the first dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis.

SOURCE Savara Pharmaceuticals
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Valeant Pharmaceuticals To Host Investor Day
2. First sales of DIFICLIR™ by Astellas Pharma Europe triggers 10 Million Euro Milestone Payment to Optimer Pharmaceuticals
3. Bausch + Lomb Completes the Acquisition of ISTA Pharmaceuticals
4. Nouveau Life Pharmaceuticals (NOUV) to Begin Sales of Azul Instant™
5. Vanda Pharmaceuticals Announces Date of Annual Meeting of Stockholders
6. SOCMAs Bulk Pharmaceuticals Task Force Welcomes House Passage of FDA Reform Act
7. Lexicon Pharmaceuticals to present at the Jefferies 2012 Global Healthcare Conference
8. Hybrid Fuels, Inc. Announces Name Change to Nouveau Life Pharmaceuticals, Inc.
9. AcelRx Pharmaceuticals Announces Pricing of a $10.0 Million PIPE Financing
10. Isis Pharmaceuticals to Present at the Goldman Sachs 33rd Annual Global Healthcare Conference
11. Auxilium Pharmaceuticals, Inc. to Present at the Goldman Sachs Global Healthcare Conference 2012
Post Your Comments:
(Date:11/26/2015)... November 26, 2015 --> ... use SyMRI to find optimal contrast weighting of MRI ... and has signed a research agreement with SyntheticMR in order ... Using SyMRI, it is possible to generate multiple contrast images ... the patient has left, thus making it possible to both ...
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Japanese therapeutic drug monitoring ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "2016 Future ... Drugs of Abuse Testing Market: Supplier Shares, ... report to their offering. --> ... of the "2016 Future Horizons and ...
Breaking Medicine Technology:
(Date:11/27/2015)... Raleigh, NC (PRWEB) , ... November 27, 2015 , ... ... most effective ways to treat it. Surviving Mesothelioma has just posted the findings ... Researchers at University Hospital Zurich analyzed the cases of 136 mesothelioma patients who were ...
(Date:11/27/2015)... ... November 27, 2015 , ... The print component ... Today in Atlanta, Dallas, New York, Minneapolis, South Florida, with a circulation of ... distributed nationally, through a vast social media strategy and across a network of ...
(Date:11/27/2015)... Wilmington, DE (PRWEB) , ... November 27, 2015 ... ... a member of the well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as ... is an independent group of Microsoft Dynamics SL software users, partners, industry experts ...
(Date:11/27/2015)... Los Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... the Commission on Accreditation of Allied Health Education Programs (CAAHEP) awarded accreditation to its ... exclusive list of CAAHEP accredited colleges, as only one of twelve colleges and universities ...
(Date:11/27/2015)... ... November 27, 2015 , ... Indosoft Inc., ... the incorporation of Asterisk 11 LTS (Long Term Support) into its Q-Suite 5.10 ... brings Q-Suite 5.10 up-to-date with a version of Asterisk that will receive not ...
Breaking Medicine News(10 mins):