XOMA UPDATES FDA REVIEW STATUS OF E5
XOMA UPDATES FDA REVIEW STATUS OF E5 BERKELEY, Calif., June 4 /PRNewswire/ -- XOMA Corp.
(NASDAQ, NMS: XOMA) today announced that is has been notified that the Food and Drug Administration (FDA) has completed its review of the company's two multicenter, randomized, placebo-controlled studies of its E5 anti-endotoxin monoclonal antibody. In April, FDA informed XOMA that the results of the first study were not sufficient to demonstrate the efficacy of E5. Unexpectedly, FDA now has advised XOMA that the agency's review of the two studies has led it to conclude that additional clinical testing may be warranted. However, no preclinical, manufacturing/control, or safety concerns were raised by FDA. In addition, FDA officials have agreed to meet with XOMA in the next week to discuss options for the ongoing review of E5.
-0- 6/4/92 /CONTACT: Carol D. DeGuzman of XOMA, 510-644-1170/ (XOMA) CO: XOMA ST: California IN: MTC SU:
RM-DG -- SF004 -- 7044 06/04/92 12:29 EDT
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|Date:||Jun 4, 1992|
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