The Clinical Development of Pexiganan for the Treatment of Diabetic Foot Infections
Warren Joseph
Consultant, Lower Extremity Infectious Diseasess, Roxborough Memorial Hospital, Philadelphia, PA
Pexiganan, a novel broad spectrum topical antibiotic peptide, has previously been studied versus the oral antibiotic ofloxacin for the treatment of diabetic foot infections. Pooled data from 2 pivotal trials demonstrated no difference in clinical outcomes between the two treatments while resistance to treatment developed in the ofloxacin arm but not the pexiganan arm. The US FDA then requested that further trial be performed to determine superiority of the active agent to its cream vehicle. A protocol was designed to test pexiganan against vehicle for "IDSA Mild Diabetic Foot Infections" while assuring aggressive safety monitoring of the patient. This is the first time a vehicle/placebo controlled trial has been attempted in the treatment of diabetic foot infections. The two Phase 3 studies are currently enrolling and being conducted under a Special Protocol Assessment from FDA.
Dr. Warren S. Joseph is a podiatric and infectious diseases attending at Roxborough Memorial Hospital in Philadelphia, PA. He is a specialist in the treatment of lower extremity infectious diseases. He received his podiatric degree, magna cum laude, from W.M. Scholl College of Podiatric Medicine in Chicago. Dr Joseph completed his postgraduate training in podiatric medicine/surgery at St. Joseph’s Hospital, and a fellowship in infectious diseases at Hahnemann University School of Medicine, both in Philadelphia.
Dr Joseph is a fellow of the Infectious Diseases Society of America and sits on the IDSA Diabetic Foot Infection Guidelines Committee. He is also certified by the American Board of Podiatric Medicine, and currently serves as Editor of the Journal of the American Podiatric Medical Association. Dr Joseph lectures extensively and his presentations have focused on the treatment of bacterial and fungal infections of the lower extremity. He has authored a number of papers and book chapters in the field of lower extremity infections and is the author of the Handbook of Lower Extremity Infections, now in its third edition.
Disclosure: Dr. Joseph serves as a paid consultant to Dipexium Pharmaceuticals