Xoma Corp. started a Phase I/II trial of its lead product, Neuprex,and plans to initiate two other trials of the recombinantbactericidal/permeability-increasing protein this quarter.
Xoma, of Berkeley, Calif., plans to study Neuprex in up to 16children suffering from meningococcemia, a severe bacterialinfection that results in endotoxin poisoning. Phase II trials of theprotein are expected to start within six weeks in trauma patientssuffering from complications associated with acute blood loss, and intreatment following partial hepatectomy (liver surgery).
"The plan covers a rather diverse field of medical and surgicalillness," Patrick Scannon, Xoma's chief scientific and medicalofficer, told BioWorld. "We want to proceed briskly into the variousareas."
Choosing diverse indications such as these maximizes theopportunity, Scannon said, and the three areas offer two advantages:the onset of the disease is clearly defined, and the primary problemwill be addressed. Therefore, results will be clear-cut, he said.
Meningococcemia, which most often affects children 1 to 6 years old,is caused by the bacterium Neisseria meningitidis, which results inthe release of high levels of endotoxins. Antibiotics usually kill thebacterium, but it releases high levels of endotoxins that can lead tocomplications, such as gangrene and stroke.
Xoma will use a low dose and high dose in the study, which isexpected to last about six months. The intent is to measure endotoxinlevels, which don't go down spontaneously, and to compare the twodoses to help assess the clinical benefit.
"Our goal with this study is to get some preliminary information sowe can move very quickly into a larger pivotal study," Scannon said."Because there are a number of other endotoxin-mediated diseases,this will serve as a model, and may provide a rationale to go intolarger market opportunities."
In 1992, Xoma's anti-endotoxin monoclonal antibody, E5, failed toget FDA approval, although Pfizer Inc., of New York, has it in aPhase III sepsis trial in the U.S., and has submitted it for marketingapproval in Japan. Last year Xoma discontinued development of itsCD5 Plus antibody conjugate in acute graft-vs.-host disease. As aresult, Xoma cut back sits work force and eliminated some earlystage programs in January.
That leaves Neuprex as the most important product for Xoma, andcompany officials said extensive studies have been conducted leadingup to the first efficacy trials. The company said 26 animal studieshave been conducted, along with a number of humanpharmacokinetic and pharmacodynamic studies. Human studiesinvolving multiple dosing regimens, and bolus and continuousinfusion administration also have been performed. The companyplans to find a development partner for Neuprex. n
-- Jim Shrine
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