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Although it may sound like the main ingredient in a witch’s brew, a new type of antibiotic compound extracted from the skin of an African frog is on its way to becoming the first drug specifically labeled for treatment of infected diabetic foot ulcers. Magainin Pharmaceuticals completed its second pivotal Phase III clinical trial of Cytolex in March and plans to submit a new drug application to the U.S. Food and Drug Administration by the end of the year.
Cytolex, a 1% topical antibiotic cream, was found to be as effective in treating the foot ulcers as ofloxacin, a popular oral antibiotic treatment. The studies showed statistical equivalence of clinical response between Cytolex and ofloxacin at day 10 of treatment, at subsequent time points through day 28, and at follow-up. The two drugs also had similar overall assessments of microbiological improvement. No side effects of Cytolex were found, which could make it a good alternative for patients who suffer from insomnia or gastrointestinal distress as a result of the oral antibiotic. The patient would apply enough of the cream to cover the ulcer twice a day.
Magainin Pharmaceuticals’ founder, Michael Zasloff, discovered 10 years ago in the African frog skin the family of peptides from which Cytolex was derived. The peptides, which he named "magainins" after the Hebrew word for shield, were found to have activity against a wide variety of pathogens. Their appeal lies in the fact that they may have the ability to kill pathogens that become resistant to traditional antibiotics. Magainin has made 2,000 derivatives of the natural antibiotic.
SmithKline Beecham will market and sell Cytolex in North America.
[Editor’s note: For more information on Cytolex, contact: Magainin Pharmaceuticals, Public Relations Department, 5110 Campus Drive, Plymouth Meeting, PA 19462. Telephone: (610) 941-4020.]