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news.Draximage, the radiopharmaceutical business unit of Draxis Health, has received approval from the FDA to run two clinical trials using I-131 MIBG to treat neuroblastoma, a rare form of cancer that affects mostly infants and young children.
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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.