A Phase III interim analysis of Magainin Pharmaceuticals Inc.'stopical cream for treating infections in diabetic foot ulcers showedthe drug, derived from peptides on the skin of frogs, is as effective asthe standard oral antibiotic, ofloxacin.
"This is very positive," said Magainin's president and CEO, JayMoorin. "It tells us the topical compound is working as well as wehoped it would."
Results of the interim analysis, conducted by a data monitoringcommittee assembled by Magainin, enable the Plymouth Meeting,Pa.-based company to proceed with its Phase III trials of thecompound, which is identified as MSI-78. The results also establish adosage level for a second Phase III trial, which will begin thissummer.
Moorin said Tuesday both studies, at 50 U.S. medical centers, shouldbe complete by the third quarter of 1996.
The trials are designed to determine if MSI-78 works as well asofloxacin, which is sold by Ortho-McNeil Pharmaceuticals ofRaritan, N.J, and is the most widely used antibiotic for treatingdiabetic foot ulcer infections. Typically, ofloxacin is 70 percent to 95percent effective in combating the infections.
Moorin said the monitoring committee reported the blinded trialsshould continue based on its "observation that there were nosignificant differences in treatment efficacy between MSI-78 [atdoses of 1 percent concentration and 2 percent concentration ] andofloxacin."
Timothy Wilson, an analyst with Hambrecht & Quist Inc. in NewYork, suggested the monitoring committee's findings on MSI-78indicate, "We have a drug."
Wall Street investors apparently were not as enthusiastic. Magainin'sstock (NASDAQ:MAGN) lost 37 cents, ending the day at $6.12.
Moorin said the interim analysis, conducted after 10 days oftreatment for 190 patients, was designed to judge the effectiveness ofMSI-78 at 1 percent and 2 percent concentrations and to determinethe appropriate dose for the second Phase III study.
Wilson also noted that after disappointing clinical studies last yeartesting MSI-78 against a placebo for impetigo, Magainin designedthe first Phase III trial for diabetic foot ulcer infections with apreliminary check to minimize expenses if the drug was notperforming. He added that two Phase III trials are needed to supportthe company's anticipated filing of a new drug application with theFDA.
Because both MSI-78 doses are working, Moorin said, the lowerconcentration will be used in the second trial for comparison withofloxacin. To avoid generating any bias for clinical investigators inthe second study, results of the first will not be released until bothPhase III trials are complete.
MSI-78 is an analog of an amino acid compound that protects theskin of African clawed frogs from a broad spectrum of infections.The frog peptides were discovered by Magainin's scientific founder,Michael Zasloff, who called the natural antibiotics, magainins, givingthe company its name. Magainin is a combination of the Hebrewword for shield and the last two letters of penicillin.
Moorin added that magainins are believed to have activity againstgram negative and gram positive infections as well as anaerobic andfungal organisms. He said the company has made 2,000 derivativesof the natural compounds.
Wilson said if MSI-78 proves successful it will have variousadvantages over ofloxacin. The topical cream apparently kills fungithe oral drug cannot and destroys other organisms that have becomeresistant to ofloxacin. In addition, Wilson said, MSI-78 apparentlyhas none of ofloxacin's side effects. n
-- Charles Craig
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