IRVING, Texas, May 2, 2014 – Reata Pharmaceuticals, Inc., announced that patient enrollment and safety evaluation in the first cohort of a Phase 1 trial of RTA 408 is now complete. The first-in-human study is evaluating the safety, tolerability, pharmacodynamic activity, and efficacy of RTA 408 when administered to patients with metastatic NSCLC and melanoma who have failed available treatment options.
Dr. Colin Meyer, Chief Medical Officer, noted that "Initial data from this study are encouraging and consistent with RTA 408's preclinical safety profile. Based on the favorable pharmacokinetic data from this first cohort, we are preparing to initiate a Phase 2 study of RTA 408 in combination with ipilimumab in patients with advanced or unresectable melanoma to exploit the immune unmasking effect of RTA 408."
RTA 408 is a novel oleanane triterpenoid that (through activation of Nrf2 and inhibition of NF-κB) suppresses tumor-driven inflammation that is believed to mask cancers from the immune system. Myeloid-derived suppressor cells (MDSCs) produce large amounts of reactive oxygen (ROS) and nitrogen species (RNS) in the tumor micro-environment. ROS and RNS act as a molecular "cloak" that prevents killer T-cells from recognizing tumor antigen. Recent clinical studies have reported that high levels of MDSCs predict lack of response to ipilimumab and are associated with poor survival in melanoma patients. Preclinical data show that RTA 408 and analogs reduce tumor ROS and RNS levels, inhibit the activity of MDSCs, augment T-cell anticancer activity, and restore immune recognition of tumor-specific antigens, thereby enhancing the capacity of the immune system to mount an antitumor response.
For more information on this study, visit: http://clinicaltrials.gov/show/NCT02029729.
About Reata Pharmaceuticals, Inc.
Reata Pharmaceuticals, Inc. is a privately held company aiming to translate innovative research into breakthrough medicines for difficult diseases that have significant unmet needs. Reata is the leader in developing a novel class of drugs with potent transcription-regulating activity called antioxidant inflammation modulators (AIMs). AIMs activate Nrf2, promoting the production of numerous antioxidant, detoxification, and anti-inflammatory genes, and inhibit NF-κB, a transcription factor that regulates many pro-inflammatory proteins. The pharmacology of the AIMs mimics that of endogenous prostaglandin metabolites that are responsible for the orchestrated resolution of inflammation. The anti-inflammatory, cytoprotective and energy metabolism effects of AIM pharmacology have been documented in more than 250 scientific papers and are potentially relevant to a wide range of diseases.
Reata Pharmaceuticals, Inc.