Reata Pharmaceuticals Inc, a Texas based company aiming to translate cutting-edge research into breakthrough medicines, has begun to enroll patients in its Phase 2 trial of RTA 408 Lotion (3% and 0.5%) for the prevention and treatment of radiation dermatitis in breast cancer patients receiving radiation therapy.
The majority of patients who undergo radiotherapy suffer from radiation dermatitis, a condition derived from the injuries radiation therapy inflicts upon the cellular structures in the skin, causing pain, ulceration, necrosis, and fibrosis of exposed skin tissues.
Radiation dermatitis usually occurs within one to four weeks after the first sessions of radiation therapy and can have a serious impact on a patient’s quality of life, becoming a direct limitation on the radiation dosage prescribed, ultimately affecting cancer progression.
Some of the most utilized methods to prevent or minimize radiation dermatitis include moisturizing the irradiated area, use of a mild soap to keep the area clean, and minimizing exposure to potential mechanical irritants.
Nonetheless, these strategies are often inefficient and the clinical need for a treatment that can safely protect against radiotherapy damages is emergent, since currently there are no approved agents for the prevention of radiation-induced dermatitis.
PRIMROSE is a randomized, double-blind, vehicle-controlled, parallel-group Phase 2 study that will assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of RTA 408 Lotion in the treatment of patients at risk for radiation dermatitis.
Its primary and secondary outcome measures are set to grading of skin changes and development of a radiation dermatitis grade of less than 2 (based on CTCAE grading scale) due to radiation therapy following topical application of RTA 408 lotion or lotion vehicle.
Qualifications for the PRIMROSE Study
Patients who are able to enroll in this trial include adult females (18 to 75 years of age) who have been diagnosed with either ductal carcinoma in situ or non-inflammatory breast adenocarcinoma, referred for post-operative radiotherapy, with no prior radiation treatment to that breast and patients planning to undergo 3D conformal radiation therapy to the whole breast or chest wall, with or without treatment of regional lymph nodes.
“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. We are enthusiastic about investigating a therapy in an area where there is a lack of approved agents and high unmet medical need,” Dr. Colin Meyer, Reata’s Chief Medical Officer said in a company’s press release.
The medical centers currently recruiting patients in the United States include the John B. Amos Cancer Center, Georgia, the AnMed Health Cancer Center, South Carolina and the Cancer Care Northwest, Washington.