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On April 26, Ractigen Therapeutics announced its independently developedTreatment of Non-Muscle-Invasive Bladder CancerTheSmall activating RNA (saRNA)RAG-01 has been granted Investigational New Drug (IND) approval by the U.S. FDA.
Bladder cancer is a common cancer of the urinary system, with NMIBC accounting for 50%-80%. The standard treatment for NMIBC is primarily transurethral resection of bladder tumor (TURBT), but the postoperative recurrence rate is high, reaching 50%-70% within five years. Therefore, there is an urgent need to develop drugs that can effectively prevent bladder cancer recurrence and treat advanced bladder cancer.RNA Activation (RNAa) Technology Uses Double-Stranded RNA Targeting Gene Promoter Regions to Activate Gene Expression, Restoring Therapeutic Protein LevelsRNA activation technology has broad application prospects in the development of therapeutic drugs, including cancer, genetic diseases, chronic diseases, metabolic diseases, and cardiovascular and cerebrovascular diseases.RAG-01 is a double-stranded saRNA drug developed by Ractigen Therapeutics that specifically targets and activates the tumor suppressor gene p21. It activates the expression of the p21 gene through the RNAa mechanism to inhibit tumor cell proliferation and induce apoptosis and senescence.. Preclinical efficacy studies have shown that,Through Ractigen's self-developed small nucleic acid delivery system LiCO™,RAG-01 treatment significantly inhibits the growth of bladder cancer tumors in animal models and demonstrates robust safety. Currently, the Phase 1 clinical trial of RAG-01 in Australia has successfully completed dosing in three subjects.Dr. Li Longcheng, founder and CEO of Ractigen, stated: "The IND application for RAG-01 has been successfully approved by the U.S. FDA, marking a significant milestone for Ractigen and a key advancement in the global RNA activation field. We will continue to advance the clinical trials of RAG-01, hoping that it will become a revolutionary therapy, providing a more effective and safer innovative treatment option for NMIBC patients worldwide."[1] Ractigen Therapeutics' first saRNA drug RAG-01 IND application approved by U.S. FDA. Retrieved Apr 26, 2024, from https://mp.weixin.qq.com/s/k-0WKgCDWe_EcAbt6jiY5g
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