Today, Gala Therapeutics announced the launch of their early stage study, testing the efficacy of its RheOx system for treating chronic bronchitis. They have already recruited the first two patients that will be enrolled in the trial, both of whom underwent surgery on November 1st. This enrollment took place at the University of Pittsburgh’s Medical Center, and RheOx bronchial rheoplasty procedures were performed by Dr. Roy Semaan and Frank Sciurba.
This unique RheOx system targets abnormal, mucus-secreting cells in the patient’s airways with a minimally invasive procedure. This electrosurgical procedure involves a pulmonologist guiding an endoscope into the patients’ airways, then inserting the RheOx catheter. The device then administers bursts of electricity to the walls of the respiratory tract, destroying the abnormal mucous-secreting cells and allowing them to be replaced with new ones that produce less mucous.
Data presented by researchers at the European Respiratory Society in Paris months ago demonstrated that RheOx can significantly improve patients’ Quality of Life scores, decrease the number of mucous-secreting cells in biopsy specimens, and solve mucous plugging on CT scans.
In July of this past summer, the FDA granted RheOx Investigational Device Exemption approval, allowing them to conduct Early Feasibility Studies (EFS) in treatment of chronic bronchitis. This study will include 15 subjects from 5 different clinical trial sites in the US, all of whom undergoing bronchial rheoplasty. The procedure is performed in two different operations, one to treat the right lung, then the left lung one month later. Primary and secondary endpoints of the study are safety and Quality of Life scores, respectively. The latter is assessed by the Saint George’s Respiratory Questionnaire and COPD Assessment Test, with pulmonary function measured via CT scans and physician testing.
“We are pleased to partner with Gala in treating the first US patients and thus continuing the contribution of UPMC as a leader in the development of novel devices for our patients with COPD” said Frank Sciurba, MD, FCCP, Director of the Emphysema/COPD Research Center at UPMC in Pittsburgh, Pennsylvania. “RheOx offers a potential solution for an unmet need for so many patients who suffer with the persistent symptoms of chronic bronchitis, representing a personalized therapy for our patients with one type of COPD.”
Gala Therapeutics is the first to introduce a surgical pulmonary procedure that targets chronic bronchitis in the US. The disease is a form of chronic obstructive pulmonary disorder (COPD), and is estimated by the CDC to affect 8.94 million patients in the US. The disorder is characterized by chronic inflammation of the respiratory tract in addition to the excess mucous production that RheOx seeks to treat. Smoking, vaporizing, airborne chemical exposure, pollution, and other irritants put patients at risk of developing this chronic bronchitis.
“Treatment of the first subjects in the United States through the novel EFS pathway is a significant milestone for Gala Therapeutics,” said Jonathan Waldstreicher, MD, Founder and CEO of Gala. “We look forward to enrolling additional patients at new US clinical sites in the coming weeks.”
Gala Therapeutics launches RheOx chronic bronchitis trial https://t.co/rdfwnDEjor
— Randy S. Benedict (@randySbenedict) November 5, 2018