Jubilant Initiates I-131 MIBG OPTIMUM Trials

Jubilant Life Sciences has announced that its wholly own subsidiary Jubilant Pharma, through one of its units Jubilant DraxImage Inc. Montreal, Canada, has initiated OPTIMUM trial which is a Pivotal Phase II Clinical Trial designed to prove the safety and effectiveness of I-131 MIBG for the treatment of neuroblastoma. The study will include both male and female patients over the age of one year who show a return or persistence of this disease following initial therapy. Children enrolled in the OPTIMUM trial could receive up to two dose cycles of I-131 MIBG over a 26-week period.

The information collected from this study will be submitted to the United States Food and Drug Administration (FDA) under the Orphan Drug Designation program and is eligible for accelerated approval if the clinical trials are successful. Jubilant’s MIBG has already been used for over a decade in USFDA approved expanded access trials and two Pediatric Oncology academic consortiums – NANT (New Approaches to Neuroblastoma Therapy) and COG (Children’s Oncology Group). – Business Standard