Centocor Ends Testing of Flagship Drug Centoxin
MALVERN, Pa. (AP) _ The struggling biotech concern Centocor Inc. said it has ended clinical trials of the anti-bacterial drug it hoped would be a blockbuster following a string of unexplained deaths.
But Centocor insisted Monday that the sepsis-fighting drug, Centoxin, is safe and blamed flawed testing for its problems.
Clinical trials of Centoxin were suspended Jan. 18 after preliminary data showed patients receiving the drug were dying at a slightly greater rate than those who received a placebo.
Centocor said the drug should have been administered only to patients near death because of infection, not to the patients in earlier stages of infection included in the study.
Centocor shares, which traded as high as $35.25 a piece over the past year, were battered after the company suspended testing of Centoxin. In over-the- counter trading Monday, Centocor fell 25 cents to $7.25 a share.
The company has not given up entirely on Centoxin. Centocor said it hoped to design new studies with sicker patients that could help win federal regulatory approval eventually.
Centoxin is designed to treat gram negative sepsis and septic shock.
Gram-negative bacterial infections kill about 500,000 Americans each year. Sepsis, the most common cause of death in medical and surgical intensive-care units, most often occurs after surgery or traumatic injuries.
Before the trials, the drug’s developers presumed Centoxin had no effect on patients with other types of bacterial infections. The patients who were dying at a greater rate were those who did not have gram-negative sepsis.
Centoxin has been approved for marketing in Europe, but the company suspended sales there in January.