Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA

Privately-held Polaris Group has received orphan drug designation for ADI-PEG 20 (pegylated arginine deiminase) from the US Food and Drug Administration.

The designation has been granted for the treatment of malignant pleural mesothelioma in the USA and the European Union, following a successful randomized Phase II trial in argininosuccinate synthetase-deficient MPM patients with ADI-PEG 20 as monotherapy.

Polaris is currently conducting a Phase I 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. It is also investigating the therapy for other diseases, including breast cancer, melanomas, ovarian cancer, and hepatocellular carcinoma. A Phase III trial is currently underway for ADI-PEG 20 as a monotherapy to treat hepatocellular carcinoma.