DelMar Pharma: FDA has granted Fast Track designation for the company's lead product candidate, VAL-083, in recurrent glioblastoma
This Fast Track status applies to two ongoing clinical trials sponsored by DelMar Pharmaceuticals to evaluate VAL-083 as a potential treatment for rGBM. These trials include:
- A Phase 2 study in bevacizumab-nave MGMT-unmethylated GBM patients conducted in collaboration with The University of Texas MD Anderson Cancer Center; and
- A Phase 3 study of patients whose disease has progressed following prior treatment with temozolomide and bevacizumab (the STAR-3 trial).
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