Malignant ascites

For patients with malignant ascites caused by advanced or terminal cancer, there are currently no approved effective drugs available for treatment worldwide. SR-T100 has completed multiple pharmacokinetic studies, animal toxicology safety tests, and human clinical trials for oral, topical, and injectable formulations, showing that SR-T100 has high safety. These studies were conducted by the National Laboratory Animal Center and professional GLP organizations. The animal efficacy tests in ovarian cancer and liver cancer-induced malignant ascites demonstrated that SR-T100 could increase the survival rate of mice, reduce ascitic fluid accumulation, and prolong their survival time. The incidence of malignant ascites varies across different cancers, with colorectal cancer at approximately 20%, gastric cancer at 20%–40%, and ovarian cancer at 60%–80%. SR-T100 injection can effectively inhibit cancer tumors and has the potential to become a new drug for the treatment of malignant ascites in cancer patients, alleviating the suffering caused by malignant ascites.

The preclinical toxicology safety tests for rats, dogs, and related injection new drug development have been completed by a professional toxicology safety testing organization. The completed documents and data have been submitted to the Ministry of Health and Welfare's Pharmaceutical Evaluation Center for consultation regarding approval to begin the Phase I human clinical trial for the treatment of malignant ascites caused by terminal cancer. If approved, the formal human clinical trials for treating malignant ascites in cancer patients will begin in the second or third quarter of 2025. This development is of significant importance as it will help improve the quality of life and extend the lifespan of cancer patients suffering from malignant ascites, while also contributing a new chapter to Taiwan's global new drug development field.

According to the World Clinical Trials Database, there have been approximately 12 new drug clinical trials for treating malignant ascites in cancer patients over the years. Some of these trials failed, while others were discontinued due to severe side effects that worsened the patients' suffering. If the SR-T100 injection is successfully developed, it will be the only drug in the world to pass human clinical trials for the treatment of malignant ascites in cancer patients. Once the initial efficacy is confirmed, the company plans to expand into the international medical market, with unlimited market potential.