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www.fdanews.com/articles/84600-tolerrx-receives-orphan-drug-designation-from-trx4

TOLERRX RECEIVES ORPHAN-DRUG DESIGNATION FROM TRX4

February 15, 2006

TolerRx has reported that its lead product, TRX4, has received orphan-drug designation by the FDA for the treatment of new-onset Type 1 diabetes mellitus. TolerRx is currently conducting a clinical study of TRX4 in the U.S. in subjects with Type 1 diabetes. Orphan-drug designation would entitle TolerRx to exclusive TRX4 marketing rights in the U.S. for seven years should TolerRx be the first company to receive marketing approval for this type of therapeutic drug product.