Seragen Inc. announced Monday that it has submitted a newdrug application (NDA) with FDA to begin Phase I clinical trialson its IL-2 receptor-targeted fusion toxin in HIV-infectedpatients.

The drug, DAB389IL-2, inhibits the replication of both labstrains of HIV-1, as well as fresh clinical isolates in culturedhuman lymphocytes. Researchers Lin Zhang and ClydeCrumpacker of Boston's Beth Israel Hospital reported theseresults in the December Journal of AIDS.

Richard Svrluga, president and chief executive officer of theHopkinton, Mass., company (NASDAQ:SRGN), said that the invitro results "build on an initial pre-clinical study (Science,June 1991) which reported effects of our first IL-2 fusion toxin,DAB486IL-2, on HIV-1."

Seragen's fusion toxin is directed specifically to the high-affinity IL-2 receptor, which is expressed on the surface ofactivated immune cells. "In contrast to many other approaches,DAB389IL-2 does not target the (HIV) virus itself, but rather asurface receptor which is present on cells that are replicatingthe virus," said Jean Nichols, Seragen's senior vice president.

"DAB389IL-2 may inhibit viral replication and decrease thenumber of HIV-infected cells in the body, thus potentiallyreducing the viral burden," added Thasia Woodworth, thecompany's vice president for clinical affairs.

-- Jennifer Van Brunt Senior Editor

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