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CENTOCOR's MONOCLONAL ANTIBODIES IN CLINICAL DEVELOPMENT FOR THERAPEUTIC USES INCLUDE NEW PLATELET ANTIBODY AND PHASE III COLORECTAL ANTIBODY 17-1A

Executive Summary

Centocor currently has three monoclonal antibody therapeutic agents in clinical development in the U.S., including a just-announced platelet antibody for use as an antithrombolytic agent, Centocor President Hubert Schoemaker, PhD, reported at the annual Alex. Brown & Sons health care seminar in Baltimore on June 11. The three antibodies in clinicals include 17-1A for the treatment of colorectal and gastrointestinal cancers; an antibody to treat gram negative infections, HA-1A, under joint development with FMC; and the platelet antibody. "We believe that by having three major therapeutic programs in trial, and [by using] the antibody in different mechanistic functions," Shoemaker declared, ". . . we have the broadest based therapeutic program in the antibody field." The Centocor monoclonal antibody furthest along in development as a therapeutic agent is 17-1A, which "will go into Phase III trials in the U.S. later this year," Shoemaker said. The colorectal cancer antibody is being developed as an adjuvant therapy following surgery, Shoemaker explained. "The concept here is that the patients that have colorectal cancer surgery today go home and have to wait to find out whether or not the cancer will reoccur," he noted. "We believe that the recurrance is due to micrometastasis -- cancer cells that have spread and are probably close to the vascular system. We believe that after surgery, giving a large dose of this antibody can significantly reduce the rate of recurrance." The initial trials with 17-1A in over 400 patients "indicated a more than 50% reduction in recurrance at the two year point," Shoemaker said. Centocor's second antibody in clinicals is a human antibody, HA-1A, to treat gram negative infections. Shoemaker said he believes the Centocor antibody is the first human antibody to reach human clinical testing. "This antibody will be used in two ways," Shoemaker pointed out. "One is to treat patients in shock that have gram negative infections, while the second way is to treat patients that are at risk of shock in the more prophylactic manner." Shoemaker said that for this reason Centocor believes "it is essential that this antibody is a human antibody." The firm's third monoclonal antibody clinical project is "an antibody against the platelet, which is an antibody we haven't discussed before," Shoemaker noted. He expalined that the platelet antibody is specific against the fibrinogen receptor on activated platelets only. Consequently, Shoemaker observed, the antibody "can block the aggregation of platelets; and, therefore, block the formation of clots without inhibitting the platelet function itself and, therefore, not put the patient in a hemophilic state." Shoemaker predicted that the platelet antibody could be used as an adjuvant to tissue plasminogen activator therapy and in patients who "are at risk of getting the clot to reoccur." In addition, he noted that the antibody "could be used on patients that, for instance, have an angiogram and are at risk of getting a clot." Centocor currently markets a number of monoclonal antibody-based in vitro diagnostic tests. The company also has an in vivo test for heart imaging, Anti-myocin, in clinical trials in the U.S. In 1985, sales of the Malvern, Pa.-based monoclonal firm's diagnostic products topped $7 mil. while total revenues were $22.4 mil. generating net income of $3.5 mil.
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