Prometic Life Sciences has announced that it has received Swedish Medical Products Agency (MPA) Clinical Trial Application (CTA) approval to commence a clinical trial of its plasminogen therapy in patients suffering from chronic tympanic membrane perforation (chronic TMP).
The clinical trial is a dose escalation, randomized, placebo-controlled study designed to investigate the safety, feasibility and initial efficacy of local injections of a novel and proprietary plasminogen formulation for the treatment of chronic tympanic membrane perforation. Up to 33 adult patients are expected to be enrolled. The study will be conducted at a single center in Sweden, under the supervision of Cecilia Engmér Berglin, MD, PhD from the Department of Otorhinolaryngology at Karolinska University Hospital in Stockholm, Sweden. The Karolinska University Hospital is the second largest ear/nose/throat center in the world.
“Chronic TMP is just one of the many additional clinical indications we intend to pursue with our plasminogen therapy. It is estimated that as many as 70,000 children in the U.S. alone are diagnosed with chronic tympanic membrane perforations every year in the U.S.”, said Pierre Laurin, President and Chief Executive Officer of Prometic. “Data generated by our colleagues in Sweden, in a preclinical animal model, shows that local injections of plasminogen around a tympanic membrane perforation restore the healing process around said perforations and ultimately close these wounds. We look forward to commencing our clinical trial and taking the next steps to bring this potential therapy to patients.”