Biotech Firm Synedgen Announces Joint Collaborative Research Agreement with Cystic Fibrosis Experts From the Cincinnati Children’s Hospital Medical Center and the University of Alabama at Birmingham

Research Investigates Synedgen’s Promising New Treatment to Help Clear Airways of Cystic Fibrosis Patients

July 31, 2012–Claremont CA–For patients with cystic fibrosis (CF), thick, viscous mucus and limited mucociliary clearance inhibits the ability to clear their airways, and contributes to long-term lung damage. Synedgen, Inc. has preliminary data showing its lead molecule, a proprietary biocompatible polysaccharide derivative, PAAG, can reduce viscosity of CF sputum.  These compelling results have led to a new research agreement with leading cystic fibrosis researchers at two different CF Centers in the US to investigate PAAG as a new therapeutic to enhance airway clearance in CF patients.

Synedgen will work with Dr. John Clancy, Research Director, Division of Pulmonary Medicine at the Cincinnati Children’s Hospital Medical Center, and Dr. Steven Rowe, Director of the Center for CFTR Detection and co-Chair of the CF Foundation’s Mucus Clearance Consortium at the University of Alabama at Birmingham to advance the understanding of the potential ways PAAG can help CF patients. Drs. Clancy and Rowe will provide intellectual guidance, clinical expertise, and CF patient sputum samples. Dr. Rowe’s lab will use sensitive rheometry techniques to study the mechanisms by which PAAG interacts with sputum to reduce its viscosity. In addition, Dr. Rowe’s expertise includes examining ciliary clearance mechanisms on live cells, which will provide insight into how PAAG could help not only loosen up the sputum, but potentially help clear it from the lungs and airways.

John P. Clancy, MD is the Research Director, Division of Pulmonary Medicine Professor, at the Cincinnati Children’s Hospital Medical Center and University of Cincinnati Department of Pediatrics, and is an international leader in pulmonary research for Cystic Fibrosis. He is actively involved with the Cystic Fibrosis Foundation and advises the National Institutes of Health on Rare Disease Research Network. He is currently the Tom Boat Chair in Cystic Fibrosis Clinical and Translational Research at Cincinnati Children’s Hospital.

Steven Rowe, MD is an expert regarding the mechanistic features underlying the activity and visualization of hair-like structures, cilia, that transport mucus out of the respiratory tree and that become less effective in CF patients. Dr. Rowe also acts a Co-Chair of the CF Foundation’s Mucus Clearance Consortium, including basic and translational scientists charged with improving the mechanistic understanding of the mucus clearance defect in cystic fibrosis, and novel means to monitor the process.

During this research effort, CF sputum samples will be collected from consenting CF patients from both Cincinnati and Birmingham. In particular, sputum samples will be collected and studied from CF patients with good to poor lung function to understand the role of PAAG on these varying levels of disease severity and level of infection.

“Synedgen is excited to be working with these intellectual leaders who understand both the importance of new therapies to help CF patients and the underlying mechanisms the CF lung that reduce their ability to successfully clear mucus from the respiratory tree,” stated Synedgen President Shenda Baker. “We look forward to developing PAAG into a treatment that can have substantial impact on CF patient quality of life.”

“Currently, there is no effective treatment for mucus build up and sinus infection for CF patients,” notes Dr. William Wiesmann, Synedgen CEO. “With PAAG, we see a tremendous opportunity to improve standard of care for CF patients. We are excited to be working with these world experts in CF to provide an important therapeutic advance in CF respiratory care.”

Drs. Rowe and Clancy are dedicated to helping CF patients live longer and finding treatments for this debilitating genetic disease. Their thoughts on the challenges of airway clearance are summarized in the August 2011 Scientific American article “A Breath of Fresh Air; New Hope for Cystic Fibrosis Treatment”, an article by Dr. Clancy, Dr. Rowe and collaborator Dr. Sorscher.  “We look forward to testing whether treating the thick adherent mucus found in CF patients with PAAG improves mucus transport, which could open a new therapeutic approach to the disease,” said Dr. Rowe.

Cystic Fibrosis is a genetic disease that causes thick mucus to build up in the lungs, sinuses, digestive tract and other areas of the body. This mucus build up can cause life-threatening lung infections as well as chronic sinusitis. The Cystic Fibrosis Foundation estimates the disease effects 30,000 individuals in the United States, and 70,000 worldwide.