Polaris Group submitted ADI-PEG 20 to FDA for IND as a treatment for soft tissue sarcoma Product: Polaris Group received notification 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.

Effect on company finances and business: 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; Planned development stages: Phase 3; Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): File application IND; Upcoming development plan: Phase 3. Market: Soft tissue sarcoma is a broad term for cancers that start in soft tissues (muscle, tendons, fat, lymph and blood vessels, and nerves). These cancers can develop anywhere in the body but are found mostly in the arms, legs, chest, and abdomen.

Leiomyosarcoma is one of the most popular types of soft tissue sarcoma, and it¡¦s still hard to find a balanced treatment with limited options for STS. With the positive data from previous phase 2 trial, led by Dr. Brain Van Tine at University of Washington in Saint Louis, Polaris Group will accelerate the clinical trial by moving forward with a phase 3 trial with ADI-PEG 20 combining with chemotherapy to treat STS. It takes considerable time and expenses to develop a new drug of which success can't be guaranteed.

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