Aeris Therapeutics’ AeriSeal® System Clinical Data Demonstrate Improved Lung Function For Up To One Year In Advanced Emphysema Patients
Aeris Therapeutics, LLC have announced the publication in CHEST of data from its latest AeriSeal® System clinical trial. In the study, patients with advanced emphysema were treated with the AeriSeal System under conscious sedation. Patients experienced improved lung function for up to one year following the AeriSeal System treatment, with results similar to those reported following lung volume reduction surgery (LVRS). The data from the study are included in a publication entitled, “Bilateral Endoscopic Sealant Lung Volume Reduction Therapy for Advanced Emphysema,” which appears online as a CHEST Paper in Press (DOI 10.1378/chest.12-0421). The AeriSeal System is a minimally invasive treatment designed to reduce lung volume and improve breathing function and symptoms in patients with advanced emphysema who no longer respond to standard medical therapy. The AeriSeal System is now entering a multi-national pivotal clinical study.
Professor Mordechai Kramer, MD, FCCP, Director of the Pulmonary Institute and Lung Transplantation Program at Rabin Medical Center, Petach Tikva, Israel and lead author of the study commented, “The simplicity of the AeriSeal System procedure and ability to achieve sustained physiological and functional benefits in patients with heterogeneous and homogeneous emphysema are encouraging. Lung volume reduction with the AeriSeal System, which requires a 15-20 minute endoscopic procedure followed by a one-day hospitalization in most cases, achieved improvements in lung function that are comparable in magnitude and durability to those following traditional LVRS. Patients with advanced emphysema are in need of new treatment options and hopefully the AeriSeal System can fill that void.”
David Dove, MD, CEO of Aeris Therapeutics commented, “These data demonstrate that the AeriSeal System can improve lung function at 12 months similar to results reported with LVRS, but with substantially less morbidity. The next phase of our corporate strategy is to expand beyond our European CE Mark and begin enrolling patients in our pivotal clinical trial in order to make the AeriSeal System therapy available to advanced emphysema patients in the U.S.”
In the reported single-arm, prospective study, 20 patients – 10 with heterogeneous upper lobe disease and 10 with homogeneous disease – received treatment in two regions in each lung during a single bronchoscopic procedure. The study successfully reached its primary endpoint, reduction in upper-lobe lung volume at three months, assessed by quantitative CT analysis (P<0.001). CT imaging was performed at baseline, three months and one year post-treatment. The study also recorded improvements in lung function, symptoms, measures of oxygen exchange, and respiratory-specific, health-related quality of life in both patient groups. FEV1, a standard measure of breathing function, improved on average 25 percent at one year, and this was accompanied by mean improvements in quality of life, reflected in a seven unit reduction in St. George’s Respiratory Questionnaire, and improvements in shortness of breath, reflected in a median improvement of one unit in the Medical Research Council Dyspnea Score. Most adverse events were observed within the first 30 days of treatment and were easily managed. There were no late complications associated with therapy. The adverse event profile out to one year was satisfactory.
Growing in global prevalence, emphysema is a progressive, debilitating disease of the lung that affects as many as 60 million people worldwide. Patients with advanced emphysema currently have limited treatment choices. For many, medications, which are first line therapy, are ineffective. The AeriSeal System represents a promising option for these patients.
About the AeriSeal System
The AeriSeal System is designed to reduce lung volume without surgery to improve overall lung function in patients with advanced emphysema. The procedure involves the delivery of a liquid foam sealant into diseased areas of the lung where it polymerizes and produces collapse of the diseased area of the lung, thereby providing more space in the chest cavity to enable healthier lung to better function. It requires no special equipment, involves routine bronchoscopy technique and is usually completed in less than 20 minutes.
The AeriSeal System is approved for sale in Europe and Israel and is limited to investigational use in the United States.
Source: Aeris Therapeutics