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Polaris Group Initiates Phase 3 Trial: First Patient Successfully Dosed with ADI-PEG 20/Placebo plus Gemcitabine and Docetaxel for Difficult-to-Treat Leiomyosarcoma (LMS)

TAIPEI, Taiwan and SAN DIEGO, Calif., Dec 4 – Polaris Group (The Company, TWSE:6550), today announced that the first patient is successfully dosed in a pivotal Phase 3 trial that combines ADI-PEG 20 or placebo with traditional chemotherapy as systemic treatment in the second or third line for LMS.

The decision to move forward with this global, Phase 3 trial is based on the positive results of a Phase 2 trial. These showed that the ADI-PEG 20 plus gemcitabine and docetaxel triplet resulted in an encouraging objective response rate, especially complete responses, with prolonged duration of responses, as well as prolonged progression free and overall survival compared to historical controls. Furthermore, the Phase 2 trial clinically confirmed that lower doses of gemcitabine and docetaxel could be used with ADI-PEG 20, which was predicted by preclinical studies. These lower doses of gemcitabine and docetaxel will be used with ADI-PEG 20 in the Phase 3 trial, while the placebo group will be treated with standard doses of both agents.

ADI-PEG 20, an enzyme therapy to starve cancer cells, has emerged as a useful agent across a number of cancers. By depleting arginine, a critical nutrient for cancer cell growth, ADI-PEG 20 sensitizes LMS cells to the potent effects of chemotherapy.

Key Advantages of the Combo Strategy:

Enhanced Efficacy: The synergy between ADI-PEG 20 and chemotherapy aims to significantly enhance treatment efficacy, leading to improved outcomes.

Targeted Therapy: This combination therapy directly targets the metabolic vulnerability of LMS cells, making it a precision tool against this cancer.

Reduced Side Effects: By selectively impacting cancer cells while sparing healthy tissue, the therapy may offer a way to minimize the side effects typically associated with chemotherapy.

Personalized Approach: This approach can be customized for LMS patients, tailoring treatment to the specific characteristics of the disease and individual patient needs.

“After many years of work, I am excited that the first patient has been enrolled on the first arginine starvation registration trial in leiomyosarcoma patients. This begins an international effort to develop a therapy for sarcoma patients based on tumor metabolism.”, said Dr. Brian Van Tine, Lead Investigator of the Phase 3 as well as Phase 2 trials, and Professor of Medicine and of Pediatrics, Director Developmental Therapeutics (Phase 1) Program, and Sarcoma Program Director, Washington University in St. Louis.

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