Interim Phase I clinical trial data reported Monday at the 34thAnnual Meeting of the American Society of Hematology inAnaheim, Calif., indicate that the blood-clotting process can behalted immediately, safely and reversibly.
Researchers from the University of Alabama, Birmingham, andCorvas International Inc. of San Diego, reported that CorsevinM, Corvas' monoclonal antibody that neutralizes blood-clottingFactor VIIa, can safely inhibit blood coagulation in patientswith incurable malignancies who are otherwise clinically stable.
The 12 patients received the drug as a bolus injection at threedifferent doses. According to Howard Soule, Corvas'(NASDAQ:CVAS) vice president of product development, theintensity of the drug's action was related to the dose. Moreover,there were no adverse effects, such as immune systemreactions or bleeding problems.
Cancer patients were chosen for this study for several reasons.For one, cancer patients have a high prevalence ofdisseminated intravascular coagulation (DIC), an inappropriateclotting in blood vessels that can result in multiple organfailure, hemorrhage and death. For another, FDA prefers thatmurine monoclonal antibody-based drugs, which could cause apotential immune response, be tested in these patients ratherthan in volunteers for whom such a response might causefuture problems. "It's the same population that Centocor'sCentoxin was tested in," Soule told BioWorld. Centocor Inc.(NASDAQ:CNTO) of Malvern, Pa., is Corvas' licensee for CorsevinM.
-- Jennifer Van Brunt Senior Editor
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