Kimera® Labs Receives FDA Phase I/IIa IND Clearance For Its MSC Exosomes Human Study

Kimera® Labs Receives FDA Phase I/IIa IND Clearance For Its MSC Exosomes Human Study MIRAMAR, Fla. , May 16, 2023 /PRNewswire/ — Kimera® Labs Inc., the first and leading worldwide MSC exosome research lab and producer, is pleased to announce the FDA IND (Investigational New Drug) approval of its exosomes in a Phase I/IIa clinical trial. The trial will assess the safety and efficacy of a single intravenous dose of an isolated, proprietary placental cell line derived, mesenchymal stem extracellular vesicles for the treatment of COVID-19 symptoms in adults with mild to moderate illness. “We are excited to be one of the first companies to treat this much-needed medical condition afflicting so many people worldwide,” stated Duncan Ross , Ph.D., Founder, and CEO of Kimera Labs . “This IND will provide additional opportunities for us to target and to expand many other prevalent inflammatory-based and regenerative clinical conditions requiring our unmatched technology and capabilities.” Kimera Labs will recruit COVID-19 patients for the IV administration of its exosome products commencing in June. This Phase I/IIa study will thoroughly investigate the safety and clinical efficacy of its advanced exosome products and technology. The Company anticipates completing its Phase I/IIa trial in a matter of months, and then to seek approval to commence the final Phase 3 study. Kimera’s exosomes are produced at its 28,000 square foot state-of-the-art FDA GMP-inspected manufacturing facilities in Miramar, Florida . Kimera Labs has established a clinical and research team to prioritize future IND clinical FDA submissions to leverage the regenerative and anti-inflammatory properties of its exosomes. Read Press Release

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