Nova Pharmaceutical Corp. said Monday that it has filed aninvestigational new drug application with the Food and DrugAdministration to begin Phase I trials of its leumedin anti-inflammatory compound, NPC15669, to treat sepsis and septicshock.

Leumedins (leukocyte mediator inhibitors) inhibit theexpression of the adhesion molecule receptors on the surface ofwhite blood cells. Those receptors normally bind tocomplementary proteins on the endothelial cell surface in theblood vessel lining, enabling white blood cells to move from thebloodstream to the inflamed area. By blocking that bindingstep, leumedins prevent white blood cells from migrating intotissue to initiate inflammation.

Septic shock, a response to massive bacterial infection, ismarked by heart, liver and respiratory failure, and severeinternal bleeding. About 400,000 patients develop sepsis in theUnited States each year.

Nova shares (NASDAQ:NOVX) were up 88 cents on Monday to$6.13.

Centocor Inc. (NASDAQ:CNTO) and Xoma Corp. (NASDAQ:XOMA),whose monoclonal antibodies are closest to the market, act atan earlier stage of the septic shock process. But they work onlyon sepsis caused by gram-negative bacteria. About two-thirdsof shock patients have sepsis caused by gram-positive bacteria.

Numerous companies are targeting various phases of the sepsisprocess, including Synergen Inc. (NASDAQ:SYGN), Chiron Corp.(NASDAQ:CHIR), Genentech Inc. (NYSE:GNE), IncytePharmaceuticals Inc., Ideon Corp., Cortech Inc., Cytel Corp.(NASDAQ:CYTL), Affymax N.V. (NASDAQ:AFMXF), and RibiImmunoChem Research Inc. (NASDAQ:RIBI).

Baltimore-based Nova said it also hopes to begin Phase Iclinicals of NPC15669 for inflammatory bowel diseases in thefirst quarter of 1992. The company is conducting Phase II trialsof another leumedin compound, NPC15199, to treat contactdermatitis. Nova is developing an orally active leumedin totreat rheumatoid arthritis.

-- Karen Bernstein BioWorld Staff

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