IRVING, Texas, July 25, 2014 – Reata today announced the enrollment of the first patient in a Phase 2 dose-ranging study examining the safety, tolerability, and efficacy of RTA 408 Lotion (3% and 0.5%) versus vehicle for the prevention and treatment of radiation dermatitis in breast cancer patients for whom radiation therapy (RT) is recommended.
PRIMROSE (A Randomized Double-Blind, Vehicle-Controlled, Parallel-Group Phase 2 Study of the Efficacy Safety, Pharmacokinetics, and Pharmacodynamics of RTA 408 Lotion in the Treatment of Patients at Risk for Radiation Dermatitis) is a multi-center study in approximately 180 patients. The primary efficacy endpoint is the time-averaged effect on radiation dermatitis severity.
Radiation dermatitis is a complication experienced by a majority of patients receiving radiation therapy for cancer. RT can damage the cellular structures in the skin and cause pain, ulceration, necrosis, and fibrosis of exposed skin tissues. Radiation dermatitis usually manifests within one to four weeks after initiation of RT and can result in delays in or failure to complete RT, limiting the dose effect of RT, which can negatively affect treatment outcomes. There are currently no approved agents for the prevention of radiation-induced dermatitis.
“Based on the preclinical and Phase 1 human data, we believe that RTA 408 Lotion may have the potential to become the first treatment to prevent and mitigate radiation dermatitis in breast cancer patients undergoing radiation therapy,” noted Dr. Colin Meyer, Reata’s Chief Medical Officer. “We are enthusiastic about investigating a therapy in an area where there is a lack of approved agents and high unmet medical need.”
For more information on this study, visit: http://clinicaltrials.gov/show/NCT02142959.
About RTA 408 Lotion
RTA 408 Lotion has been assessed in a Phase 1 study which evaluated the safety, pharmacokinetics, and local pharmacodynamics of RTA 408 Lotion in 32 healthy volunteers (http://clinicaltrials.gov/show/NCT02029716). Twice daily application for up to 28 days of 0.5% and 3% RTA 408 Lotion was safe and well-tolerated on skin areas up to 500 cm2. No drug-related systemic adverse events were observed in any subject and systemic exposure was negligible.
RTA 408 Lotion also has shown efficacy in mouse models of radiation dermatitis with both fractionated and acute radiation regimens. In the fractionated radiation dermatitis model, RTA 408 Lotion demonstrated a decrease in the severity of dermatitis in mice that received a cumulative radiation dose of 60 Gray (http://www.ncbi.nlm.nih.gov/pubmed/24720753). In this study, RTA 408 Lotion treatment was associated with a 55% reduction in the percentage of days with grade ≥2 radiation dermatitis compared with vehicle controls. Further, RTA 408 Lotion is not anticipated to interfere with radiation therapy, as RTA 408 has demonstrated enhanced therapeutic efficacy when orally administered concomitantly with radiation therapy in mouse cancer models.
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 gene 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.
The Trout Group
Lee M. Stern, CFA