Ractigen Therapeutics

Single-Patient EA Policies/Criteria Ractigen Therapeutics is at the forefront of developing small activating RNA(saRNA) drugs utilizing the RNA activation (RNAa) mechanism to up-regulate endogenous gene expression. RAG-01 is a pioneering saRNA drug engineered to target and activate the tumor suppressor gene p21 via the mechanism of RNAa. It is currently being investigated in a phase Ⅰ, open label, multi-center study in patients with non-muscle-invasive bladder cancer (NMIBC) who have failed Bacillus Calmette-Guérin (BCG) therapy. We are conducting the clinical trial aiming at gaining regulatory approval to make RAG-01 available to all eligible patients as quickly as possible. Ractigen is not currently making its investigational products available on an expanded access basis anywhere in the world, as we believe that our clinical trials are the most appropriate way to access our investigational products. We encourage patients who are interested in accessing RAG-01 treatment to talk to their physician about participating in a clinical trial. If we determine that expanded access to RAG-01 becomes appropriate in the future, this policy will be updated. If you have further questions, please feel free to contact us at expanded.access@ractigen.com with any questions. Consistent with the 21st Century Cures Act, Ractigen Therapeutics may revise this policy at any time.