Phase 1
Phase 2
Phase 3
CX-01 is in development for the first-line treatment of AML. Data from a Phase 2 study presented at the 2019 ASCO conference indicated an advantage across multiple endpoints for patients treated with 0.25 mg/kg/hr CX-01. In the evaluable patient population, results of the 0.25 mg/kg/hr CX-01 arm compared favorably to the control arm: complete response rate of 89% vs. 58% (p=0.03), median event-free survival of 23.4 months vs. 9.0 months (p=0.011), and median overall survival which had not yet been reached on the CX-01 arm vs. 11.2 months (p=0.042). Chimerix plans to initiate a Phase 3 study of CX-01 in mid-2020. CX-01 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for the treatment of AML. Read more here.
Brincidofovir is being developed for smallpox under the FDA’s Animal Rule, which allows for testing of investigational drugs in animal models to support effectiveness in diseases that are not ethical or feasible to study in humans. Results from studies of brincidofovir in rabbit and mouse models of smallpox showed improved survival, even when treatment was initiated during the course of disease. Learn more about the studies here and here.