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Clinical Trials

Polaris initiates Phase I prostate cancer trial

PBR Staff Writer Published 12 January 2012

Polaris has initiated Phase I trial evaluating its cancer therapeutic, pegylated arginine deiminase (ADI-PEG 20), in combination with docetaxel in advanced solid tumors with emphasis on prostate cancer patients.

In the combination trial, patients will receive weekly intramuscular injections of ADI-PEG 20 until disease progression.

The primary endpoints of the study are safety and efficacy, and secondary endpoints will include finding the maximum tolerated dose of ADI-PEG 20 with docetaxel.

Docetaxel is currently approved for the treatment of several malignancies, including breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of the head and neck.

Polaris medical affairs executive vice president John Bomalaski said ADI-PEG 20 is a promising cancer therapeutic not only as monotherapy but in combination therapy.

"We look forward to continuing clinical development in these and in other areas to understand the full potential for this therapeutic," Bomalaski added.