Patients are being enrolled for a Phase III study of CytRx Corp.'s(NASDAQ:CYIR) drug RheothRx as a treatment for heart attackpatients. The trial will involve 9,000 patients at 350 investigationalsites in 18 countries.Under a 1990 agreement, the entire development cost of the trial,which CytRx estimates may exceed $40 million, is being borne by theWellcome Foundation Ltd., a British company; its U.S. subsidiary,Burroughs Wellcome Co., of Research Triangle Park, N.C.; and itsCanadian subsidiary, Burroughs Wellcome, Inc. of Montreal.In addition, CytRx has received $9 million in milestone payments fromBurroughs Wellcome Co. CytRx, based in Norcross, Ga., also stands toearn $18 million based on market approvals and indications, accordingto Marty Emanuele, CytRx's vice president for preclinical research anddevelopment. For example, if RheothRx is approved as a treatment forheart attacks or strokes, it would trigger a $2 million payment fromBurroughs Wellcome Co. in each case, Emanuele said. A sickle-cellanemia approval would generate a $500,000 payment.On top of this, CytRx will receive a 15 percent royalty on U.S. salesand a 10 percent royalty on international sales for as long as there's anexisting patent, Emanuele said.In return for this largesse, Burroughs Wellcome receives worldwideresponsibility for RheothRx development, regulatory approval,manufacturing and marketing.The Phase III trial in patients with heart attacks will have twocomponents. A subgroup of patients will be given RheothRx Injectionalone. A second, larger group will be given RheothRx Injection incombination with clot-dissolving thrombolytic agents such as tPa orstreptokinase.According to Emanuele, of all patients who experience heart attacks,only 20 percent are eligible for thrombolytic therapy, which carriescertain risks. Complications that may be associated with thrombolytictreatment include additional blockages and heart tissue damage.Therefore, if RheothRx proves effective alone, it could open up a largenew market.Results of a Phase II study on RheothRx that involved 114 patients inthe U.S. were presented at the annual meeting of the American Collegeof Cardiology in March. CytRx reported that victims of heart attackswho received RheothRx Injection as an adjunct to thrombolyticsexperienced significantly less damage to heart tissue and had betterheart function than patients treated with thrombolytics alone. Thecompany also said the RheothRx-treated group had a significantlylower risk of a repeat heart attack in the days immediately followingtreatment, and that the drug was well-tolerated. n
-- Philippa Maister
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