Pexiganan Phase 3 Clinical Trials Results Published in December Is...( Experts assess likelihood of use to t...),Health

Experts assess likelihood of use to treat mildly infected diabetic foot ulcers based upon data from randomized, controlled, double-blinded multi-center clinical trials of pexiganan cream

DALLAS, Dec. 17 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) and MACROCHEM CORPORATION (OTC Bulletin Board: MACM) announced today that the results of two Phase 3 studies of pexiganan for the topical treatment of mild diabetic foot infection were published in the December 15, 2008 issue of Clinical Infectious Diseases. The publication was authored by Benjamin A. Lipsky, M.D., Veteran's Affairs Puget Sound Healthcare System and the University of Washington School of Medicine, Seattle, WA; Kenneth J. Holroyd, M.D., Vanderbilt University School of Medicine, Nashville, TN; and Michael Zasloff, M.D., Georgetown University School of Medicine, Washington, D.C. The authors concluded that based on the data from these Phase 3 studies, topical pexiganan might be an effective alternative to oral antibiotic therapy in treating diabetic patients with a mildly infected foot ulcer, and might reduce the risk of selecting antimicrobial-resistant bacteria.

Overall, 835 patients were randomized; those in each treatment arm were similar with regard to dermographic and clinical characteristics. Although study 303 failed to demonstrate equivalence, study 304 and the combined data for the 2 trials demonstrated equivalent results (within the 95% confidence interval) for topical pexiganan and oral ofloxacin in clinical improvement rates (85%-90%), overall microbiological eradication rates (42%-47%), and wound healing rates. The incidence of worsening cellulitis (2%-4%) and amputation (2%-3%) did not differ significantly between treatment arms. Bacterial resistance to ofloxacin emerged in some patients who received ofloxacin, but no significant resistance to pexiganan emerged among patie
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