By Victor Kim, MD, ATSF, AASM
A clinical trial at the Temple Lung Center aims to treat chronic bronchitis in a completely new way, by targeting the lung cells at the root of the condition. In January, Temple performed the region’s first bronchoscopic procedure using Gala Therapeutics’ “RheOx™” device to ablate cells in the lung lining that overproduce mucus in a patient with chronic bronchitis. The ablated cells should then be replaced by normal lung cells as the lung lining regenerates. Many patients may benefit from this new personalized therapy in this large segment of the chronic obstructive pulmonary disease (COPD) population.
Chronic bronchitis affects approximately 9 million Americans, and is characterized by excessive phlegm, coughing and shortness of breath lasting for at least two years, often persisting despite treatment with inhalers. The condition occurs when the cells lining the bronchi are chronically inflamed (often due to smoking), causing them, over time, to secrete excessive amounts of mucus that causes breathing issues. If clinical trials with RheOx™ are successful, it could be the first FDA-approved therapy to target these mucus-overproducing cells, potentially opening a doorway to treatment for patients across the country whose condition has not responded to other therapies.
The RheOx™ electrosurgical system, an investigational device developed by Gala Therapeutics, was granted Investigational Device Exemption approval by the FDA in July 2018. Data presented at the European Respiratory Society in September 2018 demonstrated significant improvements in quality of life scores and a reduction in mucus production and plugging for patients treated outside the United States.
The Early Feasibility Study of RheOx™ is taking place at seven trial sites, and will enroll up to 15 patients total. The primary goal is to ensure the treatment is safe for subsequent trials, but the study will also use CT scans, pulmonary function tests, the COPD Assessment Test and St George’s Respiratory Questionnaire to evaluate improvement in the patient’s condition post-procedure. The procedure is performed in two sessions one month apart, treating the right lung and then the left lung airways. To learn more about this clinical trial, please contact 215-707-1359. ■