The FDA gave permission to Magainin Pharmaceuticals Inc. to goahead with the first of two Phase III multicenter pivotal trials of itstopical anti-infective compound, MSI-78, for treatment of infecteddiabetic foot ulcers.Tuesday's announcement by the Plymouth Meeting, Pa., companycame only a week and a day after Magainin released results of MSI-78in a Phase IIb/III study for impetigo, which showed threeconcentrations of the drug and the control vehicle all achieved a 75percent clinical cure rate. That trial continues to be deferred.The blinded, randomized diabetic foot ulcers study will involve morethan 300 patients and is expected to get under way this summer,Magainin president Jay Moorin told BioWorld. He said an interim lookat safety and efficacy will be taken after 130 patients have been treated.In the trial, MSI-78 will be evaluated for clinical and microbiologicalcure of infection against an orally administered antibiotic. Moorin saidthe choice of that antibiotic is the only detail pending in the test'sprotocol."In our view it is better to run a well-controlled, blinded study that hasthe power and statistics to try and make a decision, than to runsomething smaller that's not so statistically controlled," Moorin said."What we're looking for are conclusions."The company's plan, Moorin said, was to go directly from the impetigostudy to diabetic foot ulcers, which keeps the company right on track."Based on our clinical testing to date, we believe that infected diabeticfoot ulcers may be the most appropriate therapeutic indication in whichto test the broad-spectrum clinical efficacy of MSI-78," said LeonardJacob, executive vice president and chief operating officer at Magainin."These patients often have a compromised immune system and, presentto the clinician, a wide array of bacterial organisms, some of which areresistant to current oral antibiotic therapy."Magainin (NASDAQ:MAGN) stock, which fell 59 percent from$13.25 to $5.38 after the April 4 announcement on the impetigo study,has not rebounded. It lost 31 cents per share Tuesday to close at $4.56.Meanwhile, the company is evaluating its options on a privateinvestment in a public entity financing that is pending, conditionedupon the registration's effectiveness, said Michael Dougherty, seniorvice president and chief financial officer of Magainin.Last month, purchase agreements were executed in which institutionalinvestors bought about 1.1 million shares at $14 per share, which wasclose to the stock's value at the time. Magainin currently has 13.3million shares outstanding.
-- Jim Shrine
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