CENTOCOR'S SEPTIC SHOCK DRUG SCORES HITNew clinical trial results published in today's issue of the NewEngland Journal of Medicine fired another salvo into the battleover rival septic shock therapies between Centocor Inc. ofBerkeley, Calif., and Xoma Corp. of Malvern, Pa.
The data indicate that Centocor's HA-1A monoclonal antibodycan significantly reduce the mortality rate in septic patientswith gram-negative bacteria in their bloodstream, includingthose who have progressed into septic shock. The study wasconducted by the HA-1A Sepsis Study Group, which iscomposed of U.S. medical centers.
HA-1A treatment had no significant effect on the outcome forthe broader group of 543 septic patients, some of whom did nothave blood-borne bacteria. These patients were treated witheither HA-1A or an albumin placebo solution. There were nosigns of toxicity connected to the treatment.
However, in those patients with confirmed gram-negativebacteremia -- the presence of gram-negative bacteria in theblood -- HA-1A treatment reduced mortality by 39 percent.Forty-five patients (49 percent) of the 95 receiving placebodied within 28 days after treatment, while 32 of the 105patients receiving HA-1A (30 percent) died.
HA-1A reduced mortality by 42 percent among patients whohad progressed to shock, one of the serious complications ofsepsis. Patients who had not progressed to shock still showedsignificant benefit -- a 33 percent reduction in mortality --from HA-1A treatment.
Centocor's HA-1A, an IgM antibody that binds to gram-negative endotoxin, is the product of a mouse/humanhybridoma. It most directly competes with Xoma's E5 mousemonoclonal antibody. Both products recognize essentially thesame region of the endotoxin molecule, and both are awaitingreview by the Food and Drug Administration.
There has been considerable debate over whether eitherproduct offers a clearly superior clinical benefit. Centocor hasmade much of the "human" nature of its product.
But both products have a similar half-life in the body -- about16 to 19 hours -- and a similar rate of allergic reactions inpatients, according to Pat Scannon, Xoma's president. He hasalso claimed that Xoma's product has shown significant benefitsin treating all patients with sepsis and not in severe shock,regardless of whether they carried gram-negative infections intheir blood. -- Cynthia Robbins-Roth, Ph.D.
(c) 1997 American Health Consultants. All rights reserved.