TOLERRX'S DIABETES DRUG GETS ORPHAN DRUG DESIGNATION

TolerRx announced that its lead product, TRX4, has received orphan drug designation from the FDA for the treatment of new-onset Type 1 diabetes mellitus. The company is currently conducting a clinical study of the drug in the U.S.

Orphan drug designation would entitle TolerRx to exclusive marketing rights for TRX4 in the U.S. for seven years should the company receive marketing approval. In addition, the designation would allow TolerRx to apply for research funding, tax credits for certain research expenses and a waiver of user fees.

In a study of subjects with new-onset Type 1 diabetes, TRX4 (ChAglyCD3) was shown to preserve the function of insulin-producing beta cells in the pancreas and reduce the amount of administered insulin needed to control blood glucose levels for at least 18 months after a single six-day course of the drug. At the doses used in this study, TRX4 administration was associated with transient symptoms of flu-like syndrome and transient EBV reactivation.