CytRx Corp. ended a Phase II trial of its drug, RheothRx, for treatmentof myocardial infarction after a separate clinical study showed thedoses being used were too high, causing a potential for increasedincidence of acute renal dysfunction."I wouldn't call it good news, but it doesn't mean it's bad news either,"said Martin Emanuele, Atlanta-based CytRx's vice president forpreclinical research and development. "It's disconcerting. The drug hasalways been well tolerated and we never worried about safety. That'swhy we pushed the dose as high as we did. Maybe we're just grosslyoverdosing the drug."News that the trial was stopped sent CytRx's stock (NASDAQ:CYTR)down $1.25 to close at $2.69 Wednesday, a 32 percent drop.Emanuele said the company's much larger Phase III trial of RheothRxfor treating myocardial infarction in combination with thrombolytics iscontinuing.The RheothRx trials are being conducted in association with BurroughsWellcome Co., of Research Triangle, N.C.The adverse side effects were discovered in the first part of the PhaseIII trial, which is a dose range study. Emanuele said five doses werebeing tested and it was determined that four of them may have beenassociated with adverse renal reactions after 600 of the 2,100 patientswere enrolled. The dose-range study is proceeding with two lowerdoses, one of which will be selected for the second phase of the PhaseIII trial involving 7,000 patients.The Phase II trial at the University of Washington, Seattle, wasdiscontinued because the dose levels being used were equivalent tothose that caused problems in the Phase III study."For that reason, Burroughs Wellcome decided to stop the trials,"Emanuele said. "We had already enrolled 196 of 250 patients and tocontinue with a lower dose didn't make sense."RheothRx is designed to improve blood flow in heart attack patients,inhibit clot formation and enable damaged tissues to heal. n

-- Charles Craig

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