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.

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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.

"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."

"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.