A patent on a potential treatment for sepsis issued Tuesday toIncyte Pharmaceuticals Inc., which is co-developing the agent withGenentech Inc. in competition with Xoma Corp.

Patent No. 5,089,274 issued to the Palo Alto, Calif., company coversuse of human bactericidal/permeability increasing protein (BPI), oranalogs or fragments of the protein, for the treatment of endotoxin-related disorders. The patent also claims ways to purify BPI, whichis made by the neutrophil white blood cells.

Xoma Corp. is also developing BPI in collaboration with scientists atNew York University who discovered the protein. NYU in 1990entered into a licensing agreement with Xoma that gave exclusiverights to BPI and fragments of BPI to the Berkeley, Calif., company(NASDAQ:XOMA). Patent applications are pending in the United Statesand elsewhere on the Xoma-NYU molecules.

Genentech (NYSE:GNE), which cloned the protein in collaboration withthe NYU researchers, in September entered into a $14 millioncollaboration with Incyte to develop BPI. The South San Francisco,Calif., company will have worldwide marketing rights except inJapan and the Far East, which Incyte retained.

Xoma spokeswoman Carol DeGuzman said the company declined tocomment on the patent. Randal W. Scott, vice president for researchat privately held Incyte, told BioWorld that "it would be some timebefore we know how (the patent) would affect our competition."BPI appears to be a powerful antibiotic that white blood cellsproduce and release to counter infections, including the body-wideinvasion of E. coli that can result in septic shock. BPI attacks andkills gram-negative bacteria, and neutralizes the toxic portion ofendotoxin released by the bacteria.

NYU scientists have shown that a fragment of BPI inhibits release oftumor necrosis factor, IL-6 and IL-8, and that the fragment protectsmice from the lethal effect of endotoxin. Various biotech companiesare developing products to counter sepsis based on TNF or theinterleukins. BPI, its developers claim, may fight sepsis betterbecause it stops the whole cascade of cytokines.

Endotoxin is also implicated in other life-threatening disorders,such as adult respiratory distress syndrome, disseminatedintravascular coagulation, and kidney failure.

-- Roberta Friedman, Ph.D. Special to BioWorld

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