Gala Therapeutics Announces First Patients Enrolled in Pivotal Trial of RheOx™ System for Chronic Bronchitis
SAN CARLOS, Calif., May 20, 2021 /PRNewswire/ -- Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, has initiated its pivotal clinical trial to evaluate its RheOx™ Bronchial Rheoplasty System for the treatment of the symptoms of chronic bronchitis. The first patient procedures in the RheSolve clinical trial were performed at UPMC in Pittsburgh by Dr. Frank Sciurba, M.D., and at OSF HealthCare Saint Francis Medical Center in Peoria, Ill., by Patrick Whitten, M.D.
The RheOx system, which was granted U.S. Food and Drug Administration Breakthrough Device Designation in 2019, is designed to improve the cough and mucus symptoms of chronic bronchitis by delivering non-thermal pulsed energy to mucus-producing cells in the lung airways.
"The symptoms associated with chronic bronchitis have a substantial impact on patients' quality of life, and currently there are no approved treatment options targeting the mucus-producing airway cells associated with the disease," said Dr. Frank Sciurba, MD, professor of medicine in the Division of Pulmonary and Critical Care Medicine at the University of Pittsburgh, and co-principal investigator. "I am encouraged by the potential for RheOx to make a difference in patients' lives, and I'm proud to be part of the leadership team for such an important study addressing this unmet need."
According to Bryan McVay, D.O., sub-investigator at OSF Saint Francis, "This is exciting to offer patients a new non-pharmacological therapy for chronic bronchitis that alleviates their symptoms and targets the cause of the disease. This study is a huge development for chronic bronchitis patients."
The RheSolve trial is a double-blind, randomized, sham-controlled study in COPD patients with moderate to severe chronic bronchitis. A total of 270 consenting participants will be randomized in a 2:1 ratio to receive treatment using RheOx or a sham procedure, at up to 40 U.S. and 10 international centers. The RheSolve trial includes a 12-month cross-over, at which point participants who receive the sham procedure and who meet certain criteria may be eligible to receive treatment with RheOx. The trial's primary efficacy endpoint is the change from baseline to six months in patient-reported symptoms using the COPD Assessment Test. Co-principal investigators are Dr. Sciurba and Arschang Valipour, MD, FCCP, Associate Professor, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Wien, Austria.
"Prior clinical studies using the first-of-its-kind RheOx system for chronic bronchitis have demonstrated compelling improvements in patient symptoms and quality of life. We are excited to begin the RheSolve pivotal trial, a key step in our pursuit to commercialize RheOx therapy to improve the lives of these patients," said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics.
Chronic bronchitis is a phenotype of COPD that involves prolonged inflammation and excess mucus production in the lung airways, causing severe coughing spells, mucus, wheezing, chest pain and shortness of breath.¹ Chronic bronchitis, affecting an estimated 9 million people in the U.S.,¹·² can develop after exposure to cigarette smoke, vaping, airborne chemicals, and other pollutants and irritants. Current treatments are directed at bronchodilation and reduction in inflammation only, without addressing the overproduction of mucus.
RheOx is designed to reduce mucus-producing cells in patients with chronic bronchitis through a minimally invasive bronchoscopic procedure. The revolutionary technology includes an electrosurgical generator and a single-use catheter that together deliver non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in the lungs, making way for new normal cells to redevelop. Patients treated with RheOx have reported improvements in symptoms and quality of life (www.galatherapeutics.com/patient-stories/)http://www.galatherapeutics.com/PatientStories. RheOx is limited by U.S. federal law to investigational use only. In 2019, RheOx received CE certification in the European Union and U.S. FDA Breakthrough Device Designation.
About Gala Therapeutics
Gala Therapeutics is a privately held medical device company based in San Carlos, Calif., that is dedicated to developing disease-modifying therapies that improve survival, quality of life, and outcomes for patients with pulmonary diseases. Formed by ATP, a leader in life sciences venture capital, Gala builds technologies to address the needs of interventional pulmonologists, thoracic surgeons, and all physicians who treat pulmonary disease.
¹Chronic Bronchitis. Retrieved April 06, 2021, from https://www.lung.org/lung-health-diseases/lung-disease-lookup/chronic-bronchitis
²FastStats - Chronic Lower Respiratory Disease. Centers for Disease Control (CDC) / National Center for Health Statistics (NCHS) 2017; https://www.cdc.gov/nchs/fastats/copd.htm