Aeris Therapeutics, Inc. (Aeris Therapeutics), is planning to complete clinical trial entitled “Phase 2 Study of the 20 mL Biologic Lung Volume Reduction (BLVR) System in Patients With Homogeneous or Upper Lobe Predominant Emphysema” for the product AeriSeal by April 2010. The study aim is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. This phase II trial is being conducted across US.
The open label, uncontrolled, single group assignment, safety/efficacy study has estimated enrollment of 33 participants. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation. It is now ongoing, but not recruiting participants. The study principal investigators are Mark Gotfried, MD Pulmonary Associates, Phoenix, AZ, Mark Dransfield, MD University of Alabama, Birmingham, AL, Gerard Criner, MD Temple University Lung Center, Philadelphia, PA, William Leeds, DO Veritas Clinical Specialties, Topeka, KS, Mark Krasna, MD St Josephs Medical Center, Towson, MD, Thomas Gildea, MD Cleveland Clinic, Cleveland, OH, Sanjiv Tewari, MD Akron Medical Center, Akron, OH, Geoffrey McLennan, MD University of Iowa Hospitals & Clinics, Iowa City, IA.
AeriSeal is indicated for lung volume reduction in minimally invasive procedures. It is used in the treatment of severe emphysema. The product is composed of a fibrin sealant. It is prepared by combining fibrin sealant with other therapeutic components and is introduced to the most damaged over-inflated regions of lung through a bronchoscope. The treatment delivers a adhesive foam that collapses and seals the treatment area, thereby reducing lung volume. This reduction in lung volume creates more space for adjacent healthier parts of the lungs to function more effectively. This aids in improving breathing by gradually shrinking the treated areas.