SmithKline Beecham plc stopped a Phase II trial of Cortech Inc.'sBradycor after a recent pharmacokinetic study of the drug in ratsresulted in deaths of the animals.

Bradycor was not associated with any adverse reactions amongparticipants of the Phase II trial. In that study the drug, a bradykininantagonist, is being evaluated as a treatment for reduction of brainswelling caused by head trauma.

Joseph Turner, Cortech's chief financial officer, said SmithKlinehalted the Phase II trial as a precautionary measure until it couldcheck the data from the small rat study, which was conducted forSmithKline by a contract research firm.

Turner said SmithKline has since performed the same animal studiesin its own laboratory and no deaths occurred, which is consistent withpast preclinical work with Bradycor. In addition, the drug has beenstudied extensively in humans without adverse events.

The animal mortality appears to have been related to problems inmixing the drug solution or administering it in the experiments at theoutside research facility.

SmithKline, Turner said, is conducting one additional rat trial toconfirm there is no problem with the drug itself. The pharmaceuticalcompany, he added, expects to resume the Phase II study in two tothree weeks.

"I don't think this reflects or presages any change in the relationshipbetween Cortech and SmithKline Beecham," Turner said, "and itdoes not reflect any changes in the plans for Bradycor."

In November 1995, SmithKline agreed to pay up to $25 million toCortech for development of Bradycor. The drug is designed to blockreceptors to bradykinin, which has been shown to produce pain andto initiate inflammatory responses and swelling.

Cortech tried unsuccessfully to develop Bradycor as a treatment forsepsis, a complicated disorder that has frustrated a parade ofbiotechnology companies.

In taking over development of the drug, SmithKline said it initiallyintended to continue ongoing clinical trials for treatment of traumaticbrain injury and pursue preclinical research for preventing braindamage caused by ischemic stroke.

Cortech's stock (NASDAQ:CTRQ) closed Wednesday unchanged at$1.87. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.