The Liposome Co. Inc. said late Wednesday that the start ofPhase III trials of its amphotericin B lipid complex have beendelayed because some batches of the drug were out ofspecification.
The Food and Drug Administration has requestedmanufacturing and production specification data beforeallowing the trials of the anti-fungal against cryptococcalmeningitis to resume.
The drug is licensed to Bristol-Myers Squibb, which ismanufacturing the drug and conducting clinical trials. Trialswere slated to begin this quarter.
Princeton, N.J.-based Liposome's shares (NASDAQ:LIPO) closeddown 38 cents on Wednesday at $9.75.
(c) 1997 American Health Consultants. All rights reserved.