Jubilant Life Sciences Ltd initiates I-131 MIBG OPTIMUM Trials
Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has announced that its wholly own subsidiary Jubilant Pharma Limited, 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 twenty-six 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).
Commenting on the occasion, Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co-Chairman and Managing Director, Jubilant Life Sciences Limited said: "We are extremely pleased that JDI can offer these critical therapeutic options to children who suffer from this rare cancer. The initiation of this pivotal trial is a crucial step for Jubilant's MIBG NDA filing and is a testimony to our Specialty R&D capability to develop complex products addressing advanced medical needs."
Shares of JUBILANT LIFE SCIENCES LIMITED was last trading in BSE at Rs.741.35 as compared to the previous close of Rs. 743.4. The total number of shares traded during the day was 9576 in over 655 trades.
The stock hit an intraday high of Rs. 747.35 and intraday low of 722.5. The net turnover during the day was Rs. 7060650.