Seragen Inc. announced Thursday that FDA has approved thecompany's application to test its interleukin-2 (IL-2) fusiontoxin in patients infected with HIV, the virus that causes AIDS.
The PhaseI/II trial involves DAB389IL-2, the Hopkinton, Mass.,company's new version of its IL-2 recepter-targeted fusiontoxin, and will determine the safety of administering the agentto HIV-infected individuals. The trial will be conducted at theBeth Israel and Boston City Hospitals in Boston and JohnsHopkins University Hospital in Baltimore.
In laboratory experiments, DAB389IL-2 was shown to inhibitHIV-1 replication in infected human lymphocytes -- cellsconsidered to be a reservoir for the virus. Viral replication wasinhibited in cells infected by laboratory strains of HIV-1 andby fresh clinical isolates, including an AZT-resistant strain ofHIV-1.
Seragen (NASDAQ:SRGN) is developing a proprietary family ofreceptor-targeted fusion toxins, which consist of toxinfragments genetically fused to a hormone or growth factor thattargets specific cell surface receptors on disease-causing cells.
The company believes the highly selective nature of itsreceptor-targeted fusion toxins may permit greater potencyand significantly fewer adverse effects than currently availableagents.
Seragen's fusion toxins have potential application in a widerange of diseases, a number of which are currently not curableor for which existing therapies offer limited clinical benefit.These diseases include certain cancers and such autoimmunedisorders as rheumatoid arthritis and Type-1 diabetes.
FDA Phase I and II clinical trials of Seragen's Il-2 receptor-targeted fusion toxin are currently in progress for severerheumatoid arthritis, recent onset type-1 diabetes andchemotherapy-resistant lymphomas.
The company's stock was up 75 cents a share on Thursday,closing at $14.25.
-- Nancy Garcia Associate Editor
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