Magainin Pharmaceuticals Inc. plans to begin a Phase IIIcomparative trial of its lead product, MSI-78, in diabetic patients inlate spring. The trial will consist of four treatment arms: MSI-78 oncea day, MSI-78 twice a day, SmithKline Beecham's Bactroban andsystemic erythromycin.
Jay Moorin, Magainin's president and chief executive officer, saidTuesday at the Hambrecht & Quist Annual Life Sciences Conferencethat the company will study MSI-78 for treatment of lower-extremity infections in diabetics (which involve Gram-negativebacteria) to get the broadest labeling for the drug. The topical anti-bacterial and anti-fungal drug is currently in a Phase IIb/III trial fortreating impetigo, which is caused by Gram-positive organisms.Magainin (NASDAQ:MAGN) of Plymouth Meeting, Pa., expects to meetwith FDA after this trial is completed in March.
MSI-78 is the first of the company's synthetic magainins to enterclinicals. In a Phase II trial, the drug was able to reduce the numberof bacteria and fungi present in a skin infection by three to fourorders of magnitude within one hour (see BioWorld, July 9).
Magainins, a family of peptide compounds isolated from frog skin,are able to kill a wide variety of pathogenic microorganisms. Moorinsaid MSI-78 is the broadest-spectrum antibiotic discovered to date.He said pathogens are becoming increasingly resistant to antibioticsand noted a lack of new classes of antibiotics under development. Hiscompany has not observed resistance to the magainins, he said.
Moorin said Magainin will probably try to prove MSI-78's efficacyagainst a broad spectrum of microorganisms before seeking FDAapproval. Bactroban, a treatment for impetigo, is the only topicalwide-spectrum antibiotic on the market.
Magainin is developing several other magainin compounds for topicaland ophthalmic usage, including MSI-420 for corneal wound healing,MSI-404 for disinfecting contact lenses and MSI-469 for use as amouthwash or toothpaste to treat periodontal disease. Magainindeveloped the latter product under an agreement with Colgate-Palmolive. Moorin said at H&Q that Colgate has until November todecide whether it will pursue an IND filing or return the drug toMagainin.
Moorin said Magainin has tested more than 380 compounds under itsagreement with Sandoz to develop systemic anti-cancer products(see BioWorld, Dec. 29, 1992).
Magainin's executive vice president and chief operating officer,Leonard Jacob, also noted that the company is working with theNational Institutes of Health's contraceptive branch to test magaininsfor use as topical microbicides against sexually transmitted diseases.The company has supplied NIH with different classes of magainins.Jacob said a magainin mimetic, MSI-753, is able to kill a variety ofbacteria and fungi upon contact.
During a break-out session at H&Q, Moorin said the company hasbeen able to reduce manufacturing costs of MSI-78 by working withAbbott Labs. "To make a gram of amino acid peptide in solid phasecosts $700 per gram," Moorin said. To make the same gram in ascaled-up solution process, as Abbott is doing, costs in the range of$35-120, he said. Using a scaled-up recombinant process will keepcosts in the $2-20 range. Jacob noted that Magainin is working with aEuropean-based manufacturer to use a recombinant manufacturingprocess.
-- Brenda Sandburg News Editor
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