Pharmaceutical Business review

Draxis cancer trials approved by FDA

One trial is a phase II study in which I-131 MIBG will be administered with intensive chemotherapy and autologous stem cell rescue for high-risk neuroblastoma patients.

The second trial is a phase I study in which two common chemotherapy agents will be administered in combination with I-131 MIBG to determine safety and tolerability in patients with resistant/relapsed high-risk neuroblastoma.

Draximage will supply I-131 MIBG to the two clinical trials following a recent decision by the University of Michigan to no longer supply I-131 MIBG to these and other clinical trials.

These two trials are expected to start in December 2006 or early 2007.