Xoma Corp. said Wednesday it is beginning the first Phase III trial ofNeuprex, for pediatric patients with severe meningococcemia.
The Berkeley, Calif., company was granted Subpart E designation forNeuprex in that indication following a small Phase I/II open labelstudy. That designation is intended to expedite development ofproducts addressing life-threatening and debilitating illnesses.
It is estimated the Phase III trial may take about two years tocomplete, but the time needed could vary depending on how manypatients are included and the incidence of illness, said Ellen Martin,Xoma's director of corporate communications. There are 16 trialsites ready in the U.S. and Canada and Xoma is looking to openadditional centers in Europe, where there is a higher incidence ofdisease, she said. Specific details of the study still are being workedout with the FDA.
Neuprex, or recombinant bactericidal/permeability-increasingprotein, is a human-host defense protein that kills bacteria,neutralizes bacterial endotoxin and inhibits the growth of new bloodvessels, Xoma said. Meningococcemia is an infectious disease causedby the bacterium Neisseria meningitidis, which results in high levelsof endotoxin in the bloodstream. Serious illness or death can occur ina few hours.
Neuprex is being evaluated in Phase II studies for complicationsfollowing a type of major liver surgery, hemorrhagic trauma, and incombination with antibiotics to treat intra-abdominal infections.
Martin said Xoma still is looking for a Neuprex partner. A $16million financing completed Oct. 1 will give the company flexibilityas it talks with potential partners, she said. (For related stories SeeBioWorld Today, Oct. 2, 1995, p. 1 and Aug. 7, 1996, p. 1.)
Xoma's stock (NASDAQ:XOMA) gained 13 cents Wednesday toclose at $4.06. _ Jim Shrine
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