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Cystic Fibrosis Foundation Therapeutics, Inc. Provides Savara $1.7 Million Award for Development of AeroVanc for MRSA Lung Infection in Cystic Fibrosis Patients



10/17/2013 10:47:30 AM

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AUSTIN, Texas
, Oct. 17, 2013 /PRNewswire/ -- Savara Pharmaceuticals announced today it has received a $1.7 million research award from Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit drug discovery and development affiliate of the CF Foundation. The award will advance the development of AeroVanc, the first inhaled antibiotic being developed to treat the increasing number of people with cystic fibrosis (CF) who have persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection. The announcement was made on the opening day of the 27th annual North American Cystic Fibrosis Conference, sponsored by the CF Foundation, where doctors, scientists and clinicians present the latest advancements in CF research, care and drug development.

"The support of the CF Foundation is yet another acknowledgment that AeroVanc addresses an unmet need for people with CF suffering from MRSA infection," said Rob Neville, Chief Executive Officer of Savara Pharmaceuticals. "The $6 million in support that Savara has received from the CF Foundation and the National Institutes of Health not only provides critical funding to advance the AeroVanc program, but is also a strong endorsement of the quality and promise of our program."

Savara is now enrolling patients for its Phase II trial of AeroVanc. It is a randomized, double-blind, placebo-controlled study in 80 CF patients with persistent MRSA lung infection, and is being conducted at 26 CF centers nationwide. The primary objective of the study is to evaluate the efficacy of AeroVanc in reducing the quantity of MRSA colony forming units in sputum cultures. The secondary objectives include evaluation of the safety of repeat dosing with AeroVanc and the efficacy of AeroVanc in improving lung function, reducing respiratory symptoms, and prolonging the time to pulmonary exacerbations and the need for other antibiotics.

"Savara's AeroVanc is a much needed investigational product, as none of the current inhaled antibiotics address the growing problem of MRSA infection," said Dr. Bonnie W. Ramsey, Director of the Center for Clinical and Translational Research at Seattle Children's Research Institute, and one of the pioneers and lead investigators of TOBI, an inhaled form of tobramycin used to treat chronic Pseudomonas aeruginosa infection in CF. "TOBI has become the cornerstone of treatment in CF, and AeroVanc has the potential to become analogous to TOBI for MRSA."

About AeroVanc
Vancomycin is an FDA-approved intravenously administered antibiotic with proven efficacy in the treatment of MRSA infections. AeroVanc is an investigational, proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. AeroVanc is currently being developed as a treatment for persistent MRSA lung infection in CF patients. By delivering vancomycin directly to the lungs, higher vancomycin concentrations are achieved at the site of infection, which is expected to lead to improved clinical efficacy. In addition, direct delivery of the drug into the lungs reduces exposure to the drug elsewhere in the body, and is thereby expected to reduce the risk of systemic drug-related side effects.

About the Cystic Fibrosis Foundation
The CF Foundation is the world's leader in the search for a cure for cystic fibrosis. The Foundation funds more cystic fibrosis research than any other organization, and nearly every CF drug available today was made possible because of Foundation support. Based in Bethesda, MD., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. The CF Foundation is a donor-supported nonprofit organization. For more information, go to www.cff.org.

Established in 2000, Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) is the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation. CFFT supports and governs activities related to cystic fibrosis (CF) drug discovery through the many stages of drug development and clinical evaluation.

About Savara Pharmaceuticals
Savara Pharmaceuticals is a specialty pharmaceutical company developing AeroVanc (vancomycin hydrochloride inhalation powder), the first dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis. For more information, please see Savara's website at www.savarapharma.com, or www.aerovanc.com, or find us on Twitter, Facebook and LinkedIn.

SOURCE Savara Pharmaceuticals



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