EARLY RESULTS: "ROCKET" A PHASE II STUDY OF RRX-001, A NOVEL TRIPLE EPIGENETIC INHIBITOR, RESENSITIZATION TO IRINOTECAN IN COLORECTAL CANCER

Background: RRx-001 is a novel broad-spectrum anticancer agent that triply inhibits DNA methyltransferases (DNA MTases), Histone Deacetylases (HDAC), and Lysine Demethylases. In the first-in-human, Phase I trial, 5/5 patients who progressed on RRx-001 treatment were resensitized to previously refractory irinotecan therapy, hinting at a generalized resensitization effect. A randomized open-label multi-part, multi-center phase II trial of RRx-001 versus regorafenib (ROCKET) is underway to explore the resensitization and/or ‘episensitization’ potential in irinotecan refractory tumors and its impact on overall survival.