Combined data from two Phase 3 trials show clinical success rates
statistically equivalent to oral antibiotic therapy
WELLESLEY HILLS, Mass., March 13 /PRNewswire-FirstCall/ -- MacroChem Corporation (OTC Bulletin Board: MACM) announced today the presentation of a poster entitled "Topical versus Systemic Antimicrobial Therapy for Treating Infected Diabetic Foot Ulcers: A Randomized, Controlled, Double-Blinded, Multicenter Trial of Pexiganan Cream." The poster will be presented at the Diabetic Foot Global Conference 2008 in Los Angeles on March 13 to 15 by Benjamin A. Lipsky, MD, FACP, FIDSA, Professor of Medicine, University of Washington and Director, Primary Care Clinic, VA Puget Sound Health Care System.
The poster presents results of two Phase 3 clinical studies, individually and combined, comparing the efficacy of an investigational topical antimicrobial peptide preparation, pexiganan acetate cream, against systemic therapy with an oral fluoroquinolone antibiotic, ofloxacin, for mildly infected diabetic foot ulcers. The authors conclude, in part, that, "The rates of clinical cure or improvement (the primary outcome of the trial) for topical pexiganan and oral ofloxacin were statistically equivalent for the combined studies."
Dr. Lipsky commented that, "To my knowledge, these combined studies are the largest on treatment of diabetic foot infections ever conducted, the only ones that have compared these two routes of therapy, and the first to demonstrate the efficacy of a topical antimicrobial in treating diabetic foot infection in active-controlled trials. Furthermore, having an effective topical therapy available as an alternative to systemic treatment focuses attention on the wound and, in the case of pexiganan, uses a new antimicrobial, while avoiding adverse systemic effects and the promotion of antibiotic resistance."
"We are very pleased that these newly analyzed data are being presented
for the first time a
|SOURCE MacroChem Corporation|
Copyright©2008 PR Newswire.
All rights reserved