T Cell Sciences Inc. and SmithKline Beecham have halted their PhaseI clinical trial designed to study the safety of T Cell's complementinhibitor sCR1 in burn patients at risk for Adult Respiratory DistressSyndrome (ARDS). T Cell has also taken over responsibility for theclinical development of the inhibitor from SmithKline Beecham undera recently signed letter of intent.T Cell, of Cambridge, Mass., said the trial, which was beingconducted by SmithKline, was halted because of the slow accrual ofburn patients. T Cell plans to file a new investigational newdrug(IND) application to study sCR1 in a larger population of ARDSpatients using a new manufacturing process developed by SmithKlineBeecham in Philadelphia. The clinical evaluation of the product willalso be broadened into a new cardiovascular indication.Data derived from the halted trial will be unblinded and studied toprovide initial safety and pharmacokinetic data before the new IND isapplied for.The new letter of intent modifies the development and licenserelationship T Cell (NASDAQ:TCEL) and SmithKline Beecham(NYSE:SBH) signed in 1989. SmithKline will have manufacturingresponsibility for both clinical and commercial supplies of material.North American marketing rights, which were subject to a jointmarketing agreement between the two companies, will be transferredto T Cell. SmithKline will have an exclusive option for sales andmarketing rights for the rest of the world except Japan, which iscovered by a three-way agreement between T Cell, SmithKline andYamanouchi Pharmaceuticals Ltd. of Japan.Susan Primrose, T Cell's manager of Corporate Development andCommunications, said T Cell conducted the pre-clinical trials and nowhas the ability to conduct clinical trials, which it did not have before._ Philippa Maister
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