The 21st Century Cures Act, enacted as US law in 2016, requires manufacturers of investigational drugs intended to treat serious diseases or conditions to make publicly available their policy for providing Expanded Access to such products. One of the C Ray’s lead products, TRC003 injection, is a therapeutic radiopharmaceutical labeled by radionuclide Actinium-225. TRC003 injection is currently being investigated as a single agent in a phase 1/2 clinical trial for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer.
C Ray understand the interest of patients in accessing TRC003 injection outside of clinical trials for potentially life-threatening disease prior to regulatory approval. However, from our perspective the most appropriate way for patients in the US to gain access to this investigational therapy is the participation in our clinical studies at the moment. Hence, we do not offer any Expanded Access program for TRC003 injection in the US.
C Ray recognizes the need for Expanded Access programs and will re-evaluate our policy based on data from ongoing and future clinical trials.
C Ray Therapeutics
EA Policies for Single Patient