PHILADELPHIA — A team of researchers led by Samir Mehta, MD, chief of the Orthopaedic Trauma & Fracture Service at the Perelman School of Medicine at the University of Pennsylvania, has received a $2.5 million grant from the Congressionally Directed Medical Research Program (CDMRP), provided through the U.S. Department of Defense (DoD), to begin Phase 2 human trials of a study that examines the effective treatment of post-surgical orthopedic infections using Microbion Corporation’s topical BisEDT drug. The University of Pennsylvania will work with a team of researchers from Microbion and the University of California-San Francisco on the trial, set to begin pending FDA approval.
“We’re honored to be given this award from the DoD, and are hopeful that the Phase 2 trial will allow us to offer improved treatments and standards of care to a significant number of patients,” said Mehta. “Orthopaedic trauma and fracture patients are at an increased risk for infection. If successful, this new treatment strategy could be a significant step toward reducing instances of amputation, disability, and even death.”
Studies show that patients requiring orthopaedic trauma surgery may be three times more likely to experience post-operative infections (8.7 percent) than patients undergoing other forms of surgery (2.8 percent) as a result of the high-energy nature of the injury. With approximately 2.6 million orthopaedic devices implanted annually in the United States, approximately 4.3 percent (112,000 patients) will suffer from a post-operative infection.
Orthopaedic extremity injuries also constitute the majority (65 percent) of combat casualties experienced in recent U.S. military conflicts. The risk of infection developing after surgical treatment of traumatic, open military wounds represents an extremely serious threat; reports indicate that military wound infection rates may be as high as 77 percent. Such infections frequently lead to death, amputation, disability, and other significant morbidity, despite the best available care.
“The goal of our study is to examine the efficacy and safety of administering a single application of Microbion’s topical BisEDT gel to infected extremity wounds,” said Annamarie Horan, MPA, PhD, director of Clinical Research for Penn Orthopaedics. “The gel is not a replacement for standard antibiotics, but the promising results of the Phase 1 trial provide strong evidence suggesting the drug may be an effective supplemental treatment.”
Phase 1 human trials of BisEDT were successfully completed in 2011. Clinical studies for Phase 2 will begin next year at the Hospital of the University of Pennsylvania, and at UCSF/San Francisco General Hospital.
Last year, the World Health Organization noted a significant rise in the rate of infections that are able to ward off antibiotic treatment. The alarming rate of antibiotic resistant infections has since been labeled a global health crisis. The research team is hopeful that future research and development of drugs like BisEDT will lead to new standards of health care and improved treatments for all patients.
Dr. Mehta and Dr. Horan do not have any financial affiliation with Microbion Corporation.
Penn Medicine is one of the world’s leading academic medical centers, dedicated to the related missions of medical education, biomedical research, excellence in patient care, and community service. The organization consists of the University of Pennsylvania Health System and Penn’s Raymond and Ruth Perelman School of Medicine, founded in 1765 as the nation’s first medical school.
The Perelman School of Medicine is consistently among the nation's top recipients of funding from the National Institutes of Health, with $550 million awarded in the 2022 fiscal year. Home to a proud history of “firsts” in medicine, Penn Medicine teams have pioneered discoveries and innovations that have shaped modern medicine, including recent breakthroughs such as CAR T cell therapy for cancer and the mRNA technology used in COVID-19 vaccines.
The University of Pennsylvania Health System’s patient care facilities stretch from the Susquehanna River in Pennsylvania to the New Jersey shore. These include the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, Chester County Hospital, Lancaster General Health, Penn Medicine Princeton Health, and Pennsylvania Hospital—the nation’s first hospital, founded in 1751. Additional facilities and enterprises include Good Shepherd Penn Partners, Penn Medicine at Home, Lancaster Behavioral Health Hospital, and Princeton House Behavioral Health, among others.
Penn Medicine is an $11.1 billion enterprise powered by more than 49,000 talented faculty and staff.