A team of researchers led by Samir Mehta, MD, chief of the Orthopaedic Trauma and 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,” says Mehta. “Orthopedic 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 orthopedic 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.
Orthopedic 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,” says Annamarie Horan, MPA, PhD, director of Clinical Research for Penn Orthopedics. “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. In June 2012, the CDMRP award team met with the FDA in Washington D.C. to discuss the team’s plan to advance to Phase 2 human clinical studies for the treatment of infections associated with orthopedic trauma. 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 healthcare and improved treatments for all patients.