Polaris announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to ADI-PEG 20 (pegylated arginine deiminase) for the treatment of malignant pleural mesothelioma (MPM). ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed.
A Phase 2 trial in argininosuccinate synthetase-deficient MPM patients with ADI-PEG 20 as monotherapy has been completed. Polaris is currently conducting a Phase 1 trial of ADI-PEG 20 in combination with pemetrexed and cisplatin, the approved first-line treatment for MPM, for the treatment of MPM and non-squamous non-small cell lung carcinoma. Clinical trials on ADI-PEG 20, both as monotherapy and in combination with other agents, for the treatment of several other indications, including breast cancer, melanomas, ovarian cancer, and hepatocellular carcinoma are also being conducted. The latter indication is currently in a global Phase 3 study featuring ADI-PEG 20 as a monotherapy.
For more information visit PolarisPharma.com.