Polaris Group has dosed the first prostate cancer patient in its Phase 1 clinical trial investigating the cancer therapeutic pegylated arginine deiminase (ADI-PEG 20) in combination with docetaxel.
ADI-PEG 20, a biologic being developed by Polaris to treat various types of cancer, works by systemically depleting the external supply of arginine, resulting in the death of arginine-dependent cancer cells while leaving the normal cells unharmed.
In the Phase 1 clinical trial, prostate cancer patients with advanced solid tumours will be treated with a standard dose of docetaxel and increasing weekly doses of ADI-PEG 20. The primary endpoints of the study include safety and efficacy, while secondary endpoints are finding the maximum tolerated dose of ADI-PEG 20 with docetaxel.
Polaris collaborators at the University of California at Davis Cancer Center determined the rationale for the combination of ADI-PEG 20 plus docetaxel using both cell-based assays, xenograft mouse models and PET imaging.
Polaris Medical Affairs executive vice-president John Bomalaski said ADI-PEG 20 is a promising cancer therapeutic, not only as monotherapy but also as combination therapy. The company intends to continue clinical development in these and other areas to understand the full potential of the therapeutic.
"ADI-PEG 20 as monotherapy is already in a Phase 3 global trial for patients with hepatocellular carcinoma and in Phase 2 trials for patients with small cell lung carcinoma or mesothelioma,'' Bomalaski added. Earlier Phase 2 clinical trials of ADI-PEG 20 have demonstrated positive results in patients with hepatocellular carcinoma or metastatic melanoma.
Docetaxel, an anti-microtubule agent, 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 Group is a privately held multinational biopharmaceutical company focused on the development of protein drugs to treat cancer and other debilitating diseases.
Caption: Micrograph of prostate adenocarcinoma, acinar type, the most common type of prostate cancer. (Image courtesy of Nephron.)