Magainin Pharmaceuticals is back on track with its topical anti-infective MSI-78, as the company said Wednesday that it is starting thefirst of two planned pivotal Phase III trials for the treatment of diabeticfoot ulcers.In May the Plymouth Meeting, Pa., company released results of aPhase IIb/III study of MSI-78 for impetigo that showed threeconcentrations of the drug and placebo all achieved a 75 percentclinical cure rate, thereby eliminating any statistical significance.Magainin President Jay Moorin told BioWorld the plan always was touse the impetigo trial as a means to the diabetic foot ulcer study."It was always our goal to treat the more serious infection of diabeticulcers," Moorin said. "What we showed in the impetigo trial is . . . wehad no adverse events related to the drug, so we clearly establishedsafety."The diabetic ulcer trial is expected to enroll between 400 and 500patients at 16 sites. It is an equivalence study comparing MSI-78topical cream against ofloxacin, an orally administered antibiotic soldby Ortho-McNeil Pharmaceuticals of Raritan, N.J. Ofloxacin is fromthe quinolone antibiotic class that is standard therapy for the condition.Initially, three groups of about 65 patients each will be given either oralofloxacin and placebo cream, or a 1 or 2 percent concentration of MSI-78 and a placebo pill. Data will be collected on days 3, 7, 10 and 14and results will be compared to see if the drug achieved similarefficacy.If the interim results are positive, which Moorin said should be knownin nine to 12 months, Magainin will complete the first trial and start asecond Phase III study.Moorin said Magainin's product would compare favorably to thequinolone-class antibiotics for a number of reasons. Bacteria have notdeveloped resistance to magainins, it could be applied topically whichfits into therapy, the price would be "very competitive, and we have aspectrum advantage," he said.MSI-78 is a synthetic magainin, a natural host-defense peptide isolatefrom frogs. The company altered the original molecule throughchemical synthesis, though it still consists of natural amino acids.While Moorin said there are a number of indications for which MSI-78might be effective, the company plans to wait at least until the interimresults of the equivalence study are in before beginning any furtherdevelopment.The company has more than $30 million in cash, which, assumingsuccess, would last about two years, he said.Magainin (NASDAQ:MAGN) stock fell 59 percent, from $13.25 to$5.38, after the April 4 announcement of the impetigo trial results,even though analysts said they still believed in the product. The stockprice rose 6 cents Wednesday, closing at $3 per share. There are 3.3million shares outstanding. n
-- Jim Shrine
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