Synedgen to Present at North American Cystic Fibrosis Conference

Innovative Treatment to Improve Lung Function and Antibiotic Effectiveness in CF Patients

October 2, 2014–Claremont CA–Cystic fibrosis (CF) is a genetic disease that causes dysfunction of the lungs and the gastrointestinal organs. In particular, very thick mucus accumulates in the lungs of CF patients. This mucus is very difficult to clear, occludes the airways, and creates an environment where bacteria can easily grow. Consequently, these patients frequently suffer from chronic biofilm infections, and ultimately succumb to pulmonary failure.

Synedgen researchers report a novel approach to treating the major challenges in the lungs of CF patients. With their collaborators at the University of Alabama, Birmingham, they have demonstrated that this inhaled polymer, based on a natural polysaccharide, decreases viscosity and cohesion of both mucus and biofilms. The polymer, PAAG, has also been shown to work together with traditional antibiotics used to treat CF patients to improve the efficacy of those drugs, even for bacteria hiding in biofilms and against multidrug resistant bacteria.

Two posters have been accepted for presentation at the National Cystic Fibrosis Meeting in Atlanta, held October 8-11, 2014. The first poster, with work led by Dr. Steven Rowe of the University of Alabama, Birmingham, focuses on the effect of PAAG to change the properties of human sputum. In addition to showing PAAG reduces viscosity and elasticity in expectorated sputum, the poster shows PAAG’s effect on human bronchial epithelial cells taken from CF patients. Although these cells were grown in a laboratory, they mimic activity in human airways: they sprout cilia, small hair-like protrusions that work together to push mucus out of the lungs in a process called mucociliary clearance. These cells also secrete thick CF mucus. The PAAG treatment reduced the airway surface liquid viscosity significantly better than controls and allowed the cilia to move with less hindrance. Other studies showed that the PAAG treated mucus flowed more freely, allowing particles to diffuse easily through the mucus.

In the second poster,the effect of PAAG on biofilms of clinical isolates taken from CF patients was studied. Pseudomonas aeruginosa, (PA) is the most common infection in CF patients. Methicillin resistant staphylococcus aureus (MRSA) and Burkholderia cepacia are additional bacteria frequently causing lung infections in CF patients, and like PA, have often developed resistance to antibiotics. PAAG significantly reduced the cohesion of and the amount of MRSA, PA, and B. cepacia biofilms after 1-hour treatment. None of the other currently used CF mucolytics showed a significant reduction in biofilms. When PAAG and Tobramycin, a commonly used antibiotic for CF patients, were used together to treat P. aeruginosa biofilms for 1 hour, PAAG significantly improved the antibiotic activity. This potentiation effect of PAAG was also observed PAAG when was co-administered with Vancomycin to MRSA biofilms and with Aztreonam against PA biofilms.

Synedgen, Inc. President Dr. Shenda Baker and Synedgen VP of Research Dr. Stacy Townsend, along with colleagues from the University of Alabama at Birmingham, will present these findings at the 28th Annual North American Cystic Fibrosis Conference October 9-11, 2014 in Atlanta, Georgia. These efforts were supported by Synedgen, NSF Alabama Bridge to Doctorate Fellowship award, funding from the CFF Mucus Clearance Consortium and the NIH, National Heart Lung and Blood Institute.

“The observation that PAAG disrupts both mucus and biofilms, making them easier to clear from the lungs and potentiating antibiotic activity, could provide tremendous benefit to CF patients,” stated Synedgen President Shenda Baker. “Our hope is that by keeping the airways clear of infection, we can improve the course of this progressive lung disease.”

Courtney Fernandez, John Watson, Hannah Bowers, Kengyeh Chu, Yao Li, Susan Birket, Marina Mazur, Vamsee Raju, Guillermo Tearney, Shenda Baker, and Steven Rowe will present “PAAG decreases viscosity and Improves Transportability of Cystic Fibrosis Mucus In Situ”. Stacy Townsend, Teodor Duro, William Wiesmann and Shenda Baker will present“Novel Biopolymer Mucolytic PAAG Prevents and Treats Biofilms formed by Cystic Fibrosis Clinical Isolates In Vitro, and Potentiates Tobramycin, Aztreonam, and Vancomycin Activity Against Pseudomonas Aeruginosa and MRSA.”

About Synedgen

Synedgen Inc. is an innovative biopharmaceutical company focused on developing novel therapies and products through its proprietary biomaterials technology platform. Product development is targeted to specifically address unmet needs for therapies to treat inflammation, damage or infection at dermal, pulmonary and gastrointestinal surfaces. Synedgen’s Corporate Headquarters, Research Laboratories and Manufacturing Facility are in Claremont CA. Additional information can be found at Synedgen’s web site at www.synedgen.com.

About the North American Cystic Fibrosis Conference

The North American Cystic Fibrosis Conference serves as a collaborative forum to advance research for the treatment and cure of CF, and is an ideal opportunity to receive state-of-the-art continuing medical education and learn about the latest products and services in CF care. The educational elements of the meeting program are targeted to physicians, nurses, research scientists, respiratory therapists, physical therapists, nutritionists, social workers, and pharmacists to share the latest research and advances in CF. The meeting is held over three days with more than 60 concurrent sessions.