Gala Therapeutics said today that it launched an early feasibility study of its RheOx system for treating chronic bronchitis, and that the first two patients in the trial have already been enrolled.
Initial patient enrollment took place at the University of Pittsburgh Medical Center, with RheOx bronchial rheoplasty procedures performed by Dr. Frank Sciurba and Roy Semaan, the Menlo Park, Calif.-based company said.
“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. 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,” UPMC Emphysema/COPD Research Center director Dr. Sciurba said in a prepared statement.
The RheOx system is an electrosurgical platform intended to target abnormal, mucus-producing cells in the airways.
The system includes a catheter, designed to be used alongside an endoscope, to deliver short bursts of electrical energy to the airway walls. The procedure is intended to replace the abnormal cells with new cells that produce less mucus, Gala Therapeutics said.
The trial aims to enroll 15 subjects at five U.S. sites, with the procedures performed in two treatment sessions. The first session treats the right lung airways and a second procedure a month later treats the left lung airways.
The primary endpoint for the trial is safety, while secondary endpoints include changes in quality of life as measured by the Saint George’s Respiratory Questionnaire and COPD Assessment Test, as well as pulmonary function testing and CT scans, the company said.
“Treatment of the first subjects in the United States through the novel EFS pathway is a significant milestone for Gala Therapeutics. We look forward to enrolling additional patients at new US clinical sites in the coming weeks,” Gala founder & CEO Dr. Jonathan Waldstreicher said in a press release.
In July, Gala Therapeutics said that it won FDA investigational device exemption approval to conduct an early feasibility study of its RheOx system designed to treat individuals with chronic bronchitis.
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