Trials & Filings

Polaris Begins AML Trial

FDA approves IND for ADI-PEG 20

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Polaris Group has filed an IND application with the FDA to begin Phase I trials to test ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, for the treatment of acute myeloid leukemia (AML). The FDA has reviewed the application, waived the 30-day review period and allowed treatment to begin. Polaris Group has previously filed other INDs under which it is conducting clinical trials on ADI-PEG 20 for the treatment of multiple other indications, including metastatic melanoma, prost...

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