Reata Pharmaceuticals Announces the Activation of an Investigational New Drug Application and Commencement of a Clinical Program in Oncology
IRVING, Texas, September 20, 2013 – Reata Pharmaceuticals, Inc., announced today the activation of an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA) Division of Oncology Products 2 for the study of RTA 408 capsules in patients with non-small cell lung cancer.
RTA 408 is a novel semi-synthetic oleanane triterpenoid that activates Nrf2 and inhibits NF-κB, thereby inducing an anti-inflammatory and antioxidant phenotype. If initially successful, the development program for RTA 408 in oncology may investigate whether the drug, when combined with other immunotherapies such as ipilumimab (Yervoy), can restore or augment cytotoxic T lymphocyte activity against tumors by suppressing the activity of a special class of immunosuppressive, immature myeloid cells called MDSCs. MDSCs are the primary cells responsible for the induction of antigen-specific T-cell tolerance in cancer, and their activity is dependent on the production of reactive oxygen species (ROS) and reactive nitrogen species (RNS). In preclinical studies, RTA 408 and analogs inhibited the production of ROS and RNS in tumors and restored T-cell recognition of tumor specific antigens in vivo.
Reata plans to initiate a first-in-human study to evaluate the safety, tolerability, pharmacodynamic activity, and efficacy of RTA 408 capsules when administered to patients with metastatic NSCLC who have failed available treatment options.
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.