DelMar Announces Fast Track Designation For VAL-083 In Recurrent Glioblastoma

(RTTNews) - DelMar Pharmaceuticals Inc. (DMPI) said that the U.S. Food and Drug Administration has granted Fast Track designation for the company's lead product candidate, VAL-083, in recurrent glioblastoma or rGBM.

The 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-naïve 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).

Outside of rGBM, DelMar has initiated a Phase 2 clinical trial of VAL-083 in newly-diagnosed MGMT-unmethylated GBM. DelMar also recently received notice of allowance from the FDA of an IND for a Phase 1/2 trial of VAL-083 in patients with recurrent platinum-resistant ovarian cancer.