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Savara Announces Formation of Clinical Advisory Board


2/26/2013 9:40:37 AM

AUSTIN, Texas, Feb. 26, 2013 /PRNewswire/ -- Savara Pharmaceuticals today announced the formation of its Clinical Advisory Board to provide clinical guidance to the company as it advances the development of its lead product, AeroVanc for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in patients with cystic fibrosis (CF).

The Clinical Advisory Board is comprised of five prominent thought leaders within the cystic fibrosis and infectious disease communities. These individuals will provide clinical knowledge and strategic guidance, as well as assist Savara in establishing deeper relationships with the CF care community in the U.S.

"We have seen MRSA lung infection grow rapidly in the CF population in recent years, and the negative effects of MRSA on lung function and the lifespan of CF patients are now well recognized," said Elliott Dasenbrook, M.D., M.H.S., Associate Director of the Adult Cystic Fibrosis Program at University Hospitals Case Medical Center.

"Savara's AeroVanc takes a proven antibiotic and combines it with an easy to use dry powder inhaler; an important step forward in addressing this significant unmet clinical need," Dr. Dasenbrook continued. Dr. Dasenbrook, the lead author of a ground breaking study in 2010 showing CF patients with persistent MRSA infection have a significantly shorter life expectancy, will act as the lead investigator for Savara's upcoming Phase II trial.

"We are very pleased to have this group of preeminent medical professionals join our Clinical Advisory Board," said Rob Neville, CEO of Savara Pharmaceuticals. "These individuals have decades of experience in the field and will provide invaluable counsel as we advance our AeroVanc clinical program this year and beyond. Their commitment to assist us in the development of AeroVanc speaks to the high importance our product may have for CF patients."

Savara plans to start enrollment in its Phase II clinical trial of AeroVanc in early April 2013. The trial is a randomized, double-blind, placebo-controlled study carried out in multiple sites around the U.S.

Members of the Clinical Advisory Board

Michael P. Boyle, M.D., F.C.C.P., Associate Professor of Medicine and Director of the Adult Cystic Fibrosis Program at Johns Hopkins Medical Institutions, Baltimore, MD.

Elliott C. Dasenbrook, M.D., M.H.S., Assistant Professor at Case Western Reserve University School of Medicine, Associate Director of the Adult Cystic Fibrosis Program at University Hospitals Case Medical Center, Cleveland, OH.

Michael W. Konstan, M.D., Professor and Chairman of the Department of Pediatrics of Case Western Reserve University School of Medicine, Director of The LeRoy W. Matthews Cystic Fibrosis Center at University Hospitals Rainbow Babies and Children's Hospital, Cleveland, OH.

Felix Ratjen, M.D., F.R.C.P.(C), Professor and Division Chief of Pediatric Respiratory Medicine at The Hospital for Sick Children, Co-leader of the Cystic Fibrosis Center at SickKids, Toronto, Canada.

Grant Waterer, M.B.B.S., F.R.A.C.P., Professor and Head of Unit at the School of Medicine and Pharmacology Royal Perth Hospital Unit at the University of Western Australia, Perth, Australia.

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. AeroVanc is being developed for the treatment of MRSA lung infection in CF patients. 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 limits its use in a chronic setting. 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 in Phase I clinical studies conducted in healthy subjects and CF patients, with a pharmacokinetic profile that supports its potential as a twice-daily treatment for pulmonary MRSA infection.

About Cystic Fibrosis and MRSA
Cystic fibrosis is a life-shortening genetic disease characterized by thick, sticky mucus in the lungs and frequent lung infections, which result in loss of lung function. As the disease progresses, the lungs of CF patients are typically infected with bacteria that are difficult to eradicate. Such infections are usually treated with inhaled antibiotics. In recent years, infection by MRSA has become increasingly common, with a prevalence of almost 30 percent of the estimated 30,000 CF patients in the United States. Persistent MRSA lung infection is associated with faster decline in lung function and a significantly shortened life expectancy. Currently there is no approved inhaled therapy for MRSA lung infection for CF 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. For more information, please see Savara's website at www.savarapharma.com.

SOURCE Savara Pharmaceuticals



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