US-based biopharmaceutical firm Reata Pharmaceuticals has enrolled the first patient in a Phase II dose-ranging trial of RTA 408 Lotion in breast cancer patients at risk for radiation dermatitis.
The trial is designed to evaluate the safety, tolerability and efficacy of RTA 408 Lotion versus vehicle for the prevention and treatment of radiation dermatitis in breast cancer patients for whom radiation therapy (RT) is recommended.
Around 180 patients will be enrolled in the multi-centre PRIMROSE trial and its primary efficacy endpoint is the time-averaged effect on radiation dermatitis severity.
Radiation dermatitis, a skin disease associated with prolonged exposure to ionizing radiation, is experienced by a majority of patients receiving radiation therapy for cancer.
Radiation therapy can damage the cellular structures in the skin and cause pain, ulceration, necrosis, and fibrosis of exposed skin tissues.
This skin disease usually manifests within one to four weeks after the start 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.
Currently, there are no approved agents for the prevention of radiation-induced dermatitis.
Reata chief medical officer Colin Meyer said: "Based on the preclinical and Phase I 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.
"We are enthusiastic about investigating a therapy in an area where there is a lack of approved agents and high unmet medical need."
In a Phase I trial, the company had evaluated the safety, pharmacokinetics and local pharmacodynamics of RTA 408 Lotion in 32 healthy volunteers.
The trial showed that twice daily application of 0.5% and 3% RTA 408 Lotion for up to 28 days was safe and well-tolerated on skin areas up to 500cm².