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Genelabs
has conducted three late-stage studies for Prestara™, an
investigational new drug licensed from Stanford University for
treatment of systemic lupus erythematosus, a disease for which
no new drug has been approved in the U.S. in more than 40 years.
Recently the FDA has indicated that one additional positive,
well-controlled clinical trial would be sufficient for the FDA
to consider reviewing a New Drug Application for approval of
Prestara for the treatment of the signs and symptoms of lupus.
In addition, Genelabs discovered the hepatitis E virus, and has
licensed to GlaxoSmithKline the rights to develop a vaccine
against this disease. GlaxoSmithKline’s vaccine candidate
recently demonstrated efficacy in preventing hepatitis E virus
infection in a clinical trial of approximately 2,000 subjects.
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