Cantex Pharmaceuticals, a clinical stage biopharmaceutical company developing proprietary pharmaceuticals that improve the treatment of cancers and other life-threatening disorders, has announced that dosing has been initiated in its phase 2 clinical trial for CX-02, Cantex's proprietary combination of disulfiram + copper (DSF-Cu), in recurrent glioblastoma. The trial's principal investigator is Jiayi Huang, M.D., at Washington University School of Medicine in St. Louis.
"Evidence found in pre-clinical studies has strongly indicated that DSF-Cu has cancer cell-killing effects against glioblastoma, breast cancer, prostate cancer, and other forms of cancer," said Stephen Marcus, M.D., chief executive officer of Cantex Pharmaceuticals, Inc. "Among the encouraging pre-clinical data is evidence that DSF-Cu can re-sensitize glioblastoma stem cells to the beneficial effects of temozolomide, the most effective existing pharmaceutical treatment of glioblastoma. With the initiation of human dosing in our phase 2 trial in recurrent glioblastoma, we look forward to exploring CX-02's potential efficacy and tolerability in this challenging illness. Glioblastoma multiforme is an aggressive malignant brain tumor in great need of new and more effective treatments."
The phase 2 multicenter, open-label, single-arm study will evaluate the efficacy, safety, and tolerability of CX-02 in approximately 20 patients with recurrent glioblastoma. The endpoints of the study will include response rate per RANO criteria, progression-free survival at six months, and overall survival. Top-line results of the endpoints evaluated in this trial are expected in late 2017 and during the first half of 2018.