Ractigen Therapeutics, announced that the FDA approved the company's Investigational New Drug (IND) application for RAG-01, a groundbreaking saRNA therapy targeting non-muscle invasive bladder cancer (NMIBC). This approval facilitates the launch of U.S. clinical trials, following the successful initiation of a Phase I trial in Australia.
RAG-01 is a pioneering therapy in bladder cancer treatment, representing the first of its kind to specifically target and activate the p21 tumor suppressor gene. This gene is critical in regulating cell cycle progression and is a key component in stopping the growth of cancer cells. By activating p21, RAG-01 offers a targeted approach to potentially curb the progression of NMIBC, a prevalent form of bladder cancer.
"FDA IND approval for RAG-01 is a major achievement for Ractigen and a significant advancement for saRNA technology worldwide," said Dr. Long-Cheng Li, Founder and CEO of Ractigen Therapeutics. "This first-in-class saRNA therapy harnesses the power of RNAa to target the p21 gene, offering a promising new option for patients with limited treatment choices. This approval validates the potential of RAG-01 as a leading saRNA therapy and strengthens our position as innovators in RNA-based treatments."
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