Trial Information

An Open-Label Treatment Protocol for the Use of Voraxaze as Adjunctive Treatment for Patients Experiencing or at Risk of Methotrexate Toxicity

This treatment protocol will be available on a cost recovery basis to IRB-approved
Investigators treating an eligible patient at any site in the US. In order to continue to
make Voraxaze™ available following FDA approval and prior to being commercially available.
Protherics needs to charge for the product, so there will be a cost to obtain Voraxaze™
under the Open-Label Treatment Protocol. Protherics is permitted under the FDA regulations
(21 CFR 312.8) to charge for Voraxaze, to recover those costs associated with its
manufacture, research and development, and handling, but do not include other commercial
costs (profit).

Patient eligibility is based on MTX concentrations and laboratory values obtained per
standard of care. Once an Investigator identifies a potential patient, he/she will contact
the Voraxaze central call center (1-877-398-9829) to receive information regarding drug
shipment. Eligible patients will have routine demographic, MTX, and Voraxaze therapy
information collected.

Each patient will receive a single dose of Voraxaze 50 Units/kg in a bolus intravenous
injection over 5 minutes. In addition to Voraxaze, patients will continue to receive
standard of care treatment including leucovorin therapy, and supportive care such as
hydration, alkalinization of urine and, if necessary, hemoperfusion/dialysis.