Polaris Group Receives IND Approval from US FDA for the Investigational New Drug of ADI-PEG 20 to Treat Soft Tissue Sarcoma

Polaris Group received approval from US clinical team of the submission of Initial Investigational New Drug Application (IND) for the development of ADI-PEG 20 as a treatment for soft tissue sarcoma. This is a randomized, double-blinded, multi-center phase 3 trial, and approximately 300 participants will be randomized in the study. The primary endpoint is PFS with OS as a secondary endpoint.

Polaris Group will keep promote the clinical application of ADI-PEG20 metabolic therapy in soft tissue sarcoma. New drug name or code: ADI-PEG 20. Purpose: Treatment for soft tissue sarcoma.