PR Newswire07.15.19
Gala Therapeutics Inc. (Gala), a clinical-stage developer of medical devices to treat pulmonary disease, has announced new results from the initial study of its investigational RheOxTM device, demonstrating the safety and feasibility of Bronchial Rheoplasty therapy to provide clinical benefit to patients with chronic bronchitis.
The initial study evaluated the investigational use of RheOx in 33 patients with chronic bronchitis, a type of Chronic Obstructive Pulmonary Disease (COPD). The device is designed to reduce cough and mucus production through a minimally invasive, bronchoscopic procedure.
"More than 9 million Americans suffer from chronic bronchitis without a therapy to reduce excess mucus production. Our Bronchial Rheoplasty procedure with RheOx is the first therapy designed to reduce mucus-producing cells and provide a better day-to-day quality of life for these patients," said Jonathan Waldstreicher, M.D., CEO of Gala Therapeutics. "We are excited by the results and intend to continue clinical development of the technology in the United States."
The Data demonstrate:
- Feasibility of Bronchial Rheoplasty, with 100 percent procedure success and an acceptable safety profile;
- Clinically meaningful improvements in patient quality of life at three months, based upon a 16.3-point mean reduction (p<0.001) in the St. George's Respiratory Questionnaire (SGRQ) and an 8.6-point mean reduction (p<0.001) in the COPD Assessment Test (CAT), with sustained quality-of-life benefits in the patients who reached 12 months;
- Symptomatic improvements at three months: A 39 percent reduction in cough (p<0.0001) and 44 percent reduction in mucus (p<0.0001); and
- A 20 percent increase in airway volume (p=0.001) and a 15.6 percent increase in identifiable airways (p=0.005), according to high-resolution computed tomography (HRCT) imaging data.
"The RheOx study showed that this approach for treating the symptoms of chronic bronchitis is technically viable, with limited device-related complications, and provides meaningful quality-of-life improvements," said study investigator Arschang Valipour, M.D., FCCP, associate professor, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto Wagner Spital, Vienna, Austria. "These findings strongly support the utility of this therapy, and I look forward to continuing clinical evaluation of RheOx."
The initial study also showed a meaningful reduction of mucus-producing cells in the airways following treatment with RheOx, according to histopathology data. The histopathology findings included a 39 percent reduction in goblet cell hyperplasia (p<0.001).
RheOx is a bronchoscopic therapy designed to deliver non-thermal energy to the airways to reduce mucus-producing cells in patients with chronic bronchitis. The technology consists of a unique 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 re-develop. Currently under evaluation in an early feasibility study in the United States, RheOx is limited by federal (or United States) law to investigational use.
Gala Therapeutics is a privately held medical device company based in Menlo Park, Calif.,, that develops disease-modifying therapies to improve survival, quality of life, and outcomes for patients with lung cancer, COPD, asthma, and other pulmonary diseases. Formed by Apple Tree Partners, a healthcare-focused venture capital firm based in New York, N.Y., Gala is building a portfolio of technologies to address the needs of interventional pulmonologists, thoracic surgeons, and all physicians who treat pulmonary disease.