Antibiotic performs well in clinical trials
Magainin Pharmaceuticals Inc. of Plymouth Meeting, PA, has reported that its first drug, an antibiotic compound, was successful in controlling infections related to diabetic foot ulcers. During Phase three clinical trials involving 342 patients, the company’s analysis of Cytolex 1.0% topical antibiotic cream revealed statistical equivalence with orally administered ofloxacin with respect to the study’s primary endpoint of the clinical response of infection after 10 days of treatment, and subsequently at 28 days follow-up. Ofloxacin is a quinolone antibiotic indicated for the treatment of skin and soft-tissue infections and is often prescribed for infected diabetic foot ulcers.Diabetic foot wounds, which are a common complication of diabetes, can become resistant to conventional antibiotics when infected and can lead to limb amputation.
The results confirmed those of a clinical investigation of 584 patients completed last year. Cytolex, a topical antibiotic cream that is derived from a compound in the skin of an African frog, is applied directly to infected areas. Thus, side effects commonly associated with oral antibiotics such as ofloxacin are avoided, according to Magainin.
If approved by the Food and Drug Administration, Cytolex will be the first drug specifically labeled for infected diabetic foot ulcers.
Preliminary analyses of adverse events in the current clinical study suggest a favorable profile for Cytolex, according to the manufacturer. Both Cytolex and ofloxacin were well-tolerated, but treatment with ofloxacin was associated with a significant excess of adverse events related to the central nervous system, particularly insomnia. "This is a strong confirmation of the efficacy and safety results observed in our initial pivotal study," says Jay Moorin, chairman and president of Magainin. "Our two studies represent, to our knowledge, the largest data base of clinical data for infected diabetic foot ulcers that has been assembled. . . . We expect that [Cytolex] will be the first antibiotic specifically labeled for the treatment of infection in diabetic foot ulcers and will provide physicians an important alternative to systemic therapy."
Magainin is a biopharmaceutical company engaged in the development of compounds from the host defense systems of animals and uses molecular techniques such as gene identification to understand the pathogenesis of disease.
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