PEG-PAL: Preliminary Phase II data

Preliminary data from an ongoing, open-label, dose-escalation, U.S. Phase II trial showed that 6 of 7 patients receiving at least 1 mg/kg/week subcutaneous PEG-PAL for at least 4 weeks had phenylalanine levels <600 µmol/L for at least 3 weeks. Specifically, median phenylalanine levels were reduced to 527 µmol/L from 1,293 µmol/L at baseline and 2 patients achieved phenylalanine levels of <5 µmol/L. An additional 16 patients have been treated with lower PEG-PAL doses at shorter time periods and are continuing to have their doses escalated according to protocol. The most common treatment-related adverse event was injection site reactions. ...