George, I am convinced more than ever antimicrobial peptides are wave of the future!!!! Humans have some neat ones but so do our little friend the frog.>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>Silver Spring, Maryland, March 4 (Bloomberg) -- Magainin Pharmaceuticals Inc. representatives told a U.S. government advisory panel that its Locilex ointment for infections in diabetic foot ulcers is safer than oral antibiotics currently used and just as effective.
Locilex, fashioned from a protein found on the skin of frogs, would be Magainin's first product on the market if approved. U.S. Food and Drug Administration officials agreed the treatment is likely to be safe, though they said in some cases Magainin's drug didn't appear to be as effective as a generic antibiotic used for comparison.
The FDA advisory panel will have to weigh those concerns against the need for a new therapy and the advantages that Magainin says its drug, also known as pexiganan, can provide.
''We believe that pexiganan provides a number of potential benefits as a novel topical antimicrobial therapy,'' said Kenneth Holroyd, senior vice president for clinical research and regulatory affairs at Magainin.
The company presented two major studies to the panel designed to show that pexiganan is equivalent to a generic antibiotic in treating infections.
The company said 85 percent of patients in one study and 89 percent in the second were cured or improved at the end of treatment with the Magainin ointment. By comparison, 91 percent of patients in the first trial and 89 percent in the second were cured or improved using the oral antibiotic, ofloxacin.
FDA reviewers said the difference between the two treatments in one of the trials was too great to consider them ''equivalent.'' They also said that the Magainin drug appeared to be less effective in reducing the size of the wound and in fighting a range of different bacteria.
70 Mln Sales Potential
If the drug is approved, the money-losing company could see sales of around $70 million a year by 2001, analysts said. The FDA usually follows the recommendations of its advisory panels, though it isn't required to do so.
''It's not a big blockbuster product, but it is a big deal for the company,'' said Meg Malloy, an analyst at Hambrecht & Quist with a ''buy'' rating on the company.
Trading in shares of the Plymouth Meeting, Pennsylvania- based company was halted as the panel met. They rose 1/8 to 3 15/16 yesterday.
If it's approved, marketing and sales of the drug will be handled in the U.S. by SmithKline Beecham Plc.
The panel will evaluate the benefits of the drug in treating diabetic foot ulcers, which the American Diabetes Association said affect almost one-third of the 15 million Americans with diabetes. The hard-to-treat sores are prone to serious infection, and foot ulcers are responsible for 85 percent of the more than 50,000 amputations among people with the disease.
The Magainin drug, used to treat infections, wouldn't compete with Johnson & Johnson and Chiron Corp.'s Regranex ointment, which speeds healing of the ulcers.
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