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Biotech / Medical : AVANT Immunotherapeutics Inc. (Nasdaq: AVAN) -- Ignore unavailable to you. Want to Upgrade?

To: 613 who wrote (359)	9/28/2001 9:47:46 AM
From: tuck	Read Replies (1) \| Respond to of 513

>>NEEDHAM, Mass., Sept. 28 /PRNewswire/ -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - news) today announced that the clinical hold placed on its TP10 pediatric trials has been removed by the U.S. Food and Drug Administration (FDA). Further, AVANT announced that it expects to resume enrollment as soon as possible in the two Phase IIb studies of its complement inhibitor, TP10, in infants undergoing cardiac surgery. As previously announced, AVANT temporarily suspended enrollment in its two Phase IIb pediatric trials of TP10 following a request from the Data Safety Monitoring Board (DSMB) for additional information. Following review of data from the trial, the DSMB unanimously recommended patient enrollment be resumed with the addition of new laboratory tests to the study protocol. On August 17, 2001, AVANT received written notification from the FDA placing the pediatric programs on clinical hold, pending the agency's review of the trial data. The agency has now completed that review, and concurred with the DSMB that enrollment can resume under the amended protocol. ``Infants enrolled in this trial are undergoing major reconstructive cardiac surgery that requires long times on cardiopulmonary bypass circuits,'' said Dr. Alistair Wheeler MD, Vice President, Medical Affairs of AVANT. ``We took appropriate action to suspend enrollment of these critically ill infants pending review by the FDA of all data. We are pleased by the FDA's conclusions and look forward to resuming enrollment in these trials once the protocol amendment has been approved by the Investigational Review Boards at each clinical site.''<< snip Cheers, Tuck