September 3, 2008
Aeris Therapeutics Announces Phase 2 Trial Results for Non-Surgical Emphysema Treatment
Aeris Therapeutics, Inc. (www.aerist.com), a company specializing in the development and commercialization of novel treatments for patients with emphysema and other advanced lung diseases, today announced that the primary efficacy endpoint in Phase 2 clinical trials for its Biologic Lung Volume Reduction (BLVR) System has been achieved. BLVR is designed to provide a safe non-surgical alternative to lung volume reduction surgery, one of the few available treatments for patients with advanced emphysema. The BLVR system is the first biologic therapy that has been successfully used to remodel the lung and improve breathing function.
"The Phase 2 clinical trial data show that BLVR is well tolerated and is associated with significant improvements in breathing function, symptoms and quality of life," commented Dr. David Dove, CEO of Aeris. "Based on these positive results, we are currently preparing for the initiation of Phase 3 trials."
Aeris conducted two U.S. Phase 2 studies enrolling 44 patients with upper lobe predominant emphysema to define the optimal dosing regimen for BLVR treatment. Additional trials focusing on the use of BLVR for homogeneous emphysema are in progress.
The primary endpoint for the Phase 2 trials was a statistically significant reduction in lung volume at three months following treatment, and was achieved in both studies. In addition, for patients in the high dose group, more than half had clinically significant improvements in breathing function, and more than three quarters had clinically significant improvements in quality of life measures, including activity level, mood and ability to work. BLVR was well tolerated and the median hospital length of stay was two days. As a comparison, patients undergoing open-chest lung volume reduction surgery have a median hospital length of stay of 10 days.
The primary endpoint was measured using the Residual Volume to Total Lung Capacity Ratio (RV/TLC). Improvement in breathing function was assessed using FEV1, a standard pulmonary function test considered to be a primary indication of lung function. This test measures the amount of air a patient can forcibly expel from his or her lungs in one second. Mean FEV1 improvements in the high dose group exceeded 17 percent at three months.
"We are very encouraged by these results, which suggest that BLVR may be a dramatically safer but still effective alternative to lung reduction surgery, an invasive procedure that involves a substantial degree of risk for emphysema patients," commented Dr. Gerard Criner, Professor of Medicine and Anesthesiology and Director of Pulmonary & Critical Care Medicine at Temple University School of Medicine and an investigator in the study. "There is a tremendous need for better options for the millions of people who suffer from emphysema."
About Emphysema and the Biologic Lung Volume Reduction System
Emphysema is a progressive, debilitating disease of the lung that affects approximately 3.8 million Americans and as many as 60 million people worldwide. Patients with emphysema currently have limited treatment choices. In recent years, lung volume reduction surgery, which involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better, has become an accepted therapy for advanced emphysema. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.
The Biologic Lung Volume Reduction (BLVR) System is a non-surgical treatment for emphysema that is currently under investigation. A bronchoscope is used to deliver a proprietary mixture of drugs and biologics that form a bioabsorbable gel at diseased areas of the lungs. The gel is a mixture of clotting agents that help deliver the treatment, an antibiotic to prevent infection, and drugs designed to cause a reaction in targeted areas of the lungs--actually using the body's natural scar formation response to permanently collapse diseased areas of the lungs. This reduction in lung volume creates more space for the non-diseased parts of the lungs to function more effectively.
About Aeris Therapeutics, Inc.
Aeris Therapeutics, Inc. is an emerging medical therapeutics company specializing in the development and commercialization of novel treatments for patients with emphysema and other advanced lung diseases. The BLVR System is designed to provide a safe, minimally invasive treatment alternative for advanced emphysema patients who currently have limited treatment options.
Founded in 2000, Aeris Therapeutics Inc. is privately held, with corporate offices in Woburn, MA.