LIPOSOME COMPANY ANNOUNCES ABLC CLINICAL TRIAL UPDATE
LIPOSOME COMPANY ANNOUNCES ABLC CLINICAL TRIAL UPDATE PRINCETON, N.J., Dec. 11 /PRNewswire/ -- The Liposome Company, Inc.
(NASDAQ: LIPO) today issued an update regarding the company's Amphotericin B Lipid Complex (ABLC). Because some batches were found to be out of product specification, clinical testing of ABLC has been put on temporary hold. This has resulted in a delay of the start of Phase III studies which were slated to begin during the fourth quarter of 1991.
During routine analytical testing it was found that some batches of ABLC manufactured for clinical trials were out of specification in that they contained aggregates of amphotericin B and lipids. As a precautionary measure, investigators were informed, trials have been put on hold while the problem is being corrected, and regulatory authorities including the U.S. Food and Drug Administration (FDA) were notified. The FDA has requested certain manufacturing and product specification data before allowing the trials to resume. Bristol-Myers Squibb, to which The Liposome Company has licensed ABLC, has been manufacturing the drug supplies and has been conducting the clinical trials. Pending the outcome of various analyses, they hope to resume clinical trials with ABLC shortly and are now in the process of developing plans to do so. The companies are working with the FDA to quickly resolve this matter. Phase III trials with ABLC are expected to begin as soon as discussions with the FDA have been satisfactory concluded. "We look forward to early resolution of this matter, so that clinical trials with ABLC can be resumed as soon as possible," said Charles A. Baker, chairman and chief executive officer of The Liposome Company. -0- 12/11/91 /CONTACT: Anne Van Lent of senior vice president of The Liposome Company, 609-452-7060/ (LIPO) CO: The Liposome Company, Inc. ST: New Jersey IN: MTC SU:
JT-SM -- NY071 -- 1593 12/11/91 16:03 EST
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|Date:||Dec 11, 1991|
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