An independent safety monitoring board concludedinterim results from a 1,700-patient Phase III trial of E5for gram-negative sepsis support continuation of the trial,Xoma Corp. said Wednesday.

Pfizer Inc., of New York _ Xoma's marketing partnerfor the anti-endotoxin monoclonal antibody _ is runningthe trial. The interim analysis was made after one-third ofpatient enrollment was completed. A second interimanalysis is scheduled after two-thirds are enrolled.

Ellen Martin, director of communications for Xoma, saidthe board looked at safety and efficacy questions in itsinterim analysis. She said the trial had to meet statisticalsignificance criteria as well as satisfy safety concerns tocontinue. On the other hand, the trial would have beenstopped had the data been overwhelmingly positive, shesaid.

The results helped push Xoma' stock(NASDAQ:XOMA) up 37 percent Wednesday, or 78cents, to $2.88.

The trial is being conducted in sepsis patients withreversible organ dysfunction, which represented asubgroup that appeared to benefit from a previous trial.The original trial, started in the mid-1980s, failed to showsurvival benefit in gram-negative sepsis patients. An 850-patient study followed when the initial study showed E5appeared to benefit patients not in refractory shock. Butthat, too, failed to show benefit, leading to the currentstudy.

"The current trial was designed after careful analysis ofextensive data from previous studies," John Castello,Xoma's president, chairman and CEO, said in a newsrelease. "This design was intended to maximize thechances of demonstrating efficacy in this difficult diseasearea. We are mindful that there is still a long way to go,but after all the sepsis setbacks reported by other firms,we are encouraged that our results support continuing thetrial."

Xoma, of Berkeley, Calif., changed its focus after thefailure of E5 to products derived frombactericidal/permeability-increasing protein. The leadcandidate from that program, Neuprex, is in three trialsfor endotoxin complications: hemorrhagic shock,meningococcemia and partial hepatectomy.

E5 still is under regulatory review in Japan as a treatmentfor endotoxin poisoning. A decision is expected there inearly or mid-1996, Martin said. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.