US-based biopharmaceutical firm Cantex Pharmaceuticals has begun dosing patients in its Phase II clinical trial of CX-02 for the treatment of recurrent glioblastoma.
CX-02 is being developed by the firm as a combination of disulfiram + copper (DSF-Cu).
The combination is expected to potentially feature mechanisms for non-overlapping cancer cell-destruction, proteasome inhibition and stimulation of reactive oxygen radicals that kill cancer cells.
The multi-centre, open-label, single-arm Phase II trial is designed to assess the efficacy, safety, and tolerability of CX-02 in up to 20 patients.
Washington University School of Medicine's Jiayi Huang has been appointed as the principal investigator of the trial.
Cantex Pharmaceuticals CEO Stephen Marcus said: "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.
"Among the encouraging pre-clinical data is evidence that DSF-Cu can re-sensitise 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 II trial in recurrent glioblastoma, we look forward to exploring CX-02's potential efficacy and tolerability in this challenging illness."
The trial's endpoints are response rate per RANO criteria, progression-free survival at six months and overall survival.
The top-line results from the trial are expected to be available later this year and in the first half of next year.
Cantex plans to further investigate CX-02 in separate Phase II trials for the treatment of metastatic prostate cancer and metastatic breast cancer.
Image: Histology of glioblastoma. Photo: courtesy of KGH via Wikipedia.