Results from PREVLAR trial Demonstrate RRx-001 protects against severe oral mucositis or blistering from radiation in first line head and neck cancer
Study published in International Journal of Radiation Oncology, Biology and Physics, also known as The Red Journal
Torrey Pines, Calif., January 19, 2022 – EpicentRx, a leading edge, clinical stage biopharmaceutical company, announced the publication of Phase 2 results of the PREVLAR trial which demonstrated that RRx-001 protects against severe oral mucositis in patients receiving radiation and chemotherapy for head and neck cancer. The study was published in the International Journal of Radiation Oncology, Biology and Physics, also known as The Red Journal.
PREVLAR, a multi-institutional, randomized trial compared the safety and efficacy of three dosing schedules of RRx-001 to mitigate oral mucositis in patients receiving concomitant chemoradiation for the treatment of oral and oropharyngeal cancers. Among the findings reported by Dr. David Sher from University of Texas Southwestern in Dallas and his colleagues in their paper “PREVLAR: Phase 2 randomized trial to assess the safety and efficacy of RRx-001 in the attenuation of oral mucositis in patients receiving head and neck chemoradiotherapy” was the observation that pre-radiation RRx-001 alone favorably impacted the incidence and duration of severe oral mucositis (SOM) safely. Importantly, RRx-001 patients responded no differently to their cancer than did patients in a control arm when evaluated two years after the completion of their chemoradiation treatment.
SOM is among the most common and symptomatically severe complications of concomitant chemoradiation used routinely to treat cancers of the head and neck. SOM occurs in approximately 70% of head and neck cancer patients. The sores or ulcerations associated with mucositis are often present throughout the mouth and throat and are associated with unmanageable pain, impaired nutrition, and dehydration, which result in more emergency room visits and hospitalizations. Most impactful on survival are the negative effects of SOM on patients’ ability to tolerate optimal treatment of their cancers.
The potential of RRx-001 as a protective agent for non-cancer, normal cells is related to its joint activities as an NLRP3 inflammasome inhibitor and activator of the Nrf2 antioxidant transcription factor. A larger Phase 2 randomized study named KEVLAR is planned with RRx-001 for further clinical evaluation of oral mucositis prevention.
Dr. Stephen Sonis, Harvard Professor of Oral Medicine and member of the Distinguished Faculty of the Dana-Farber Cancer Institute, and manuscript co-author, commented that “the results noted in PREVLAR suggest that RRx-001 may provide protection from severe radiation-associated mucositis with a dosing schedule that is highly desirable for both patients and radiation oncologists. I look forward to further study of this treatment in the subsequent KEVLAR study.”
The lead EpicentRx small molecule, RRx-001 is a highly selective NLRP3 inhibitor with vascular normalization and tumor associated macrophage polarization properties that resensitizes tumors to previously administered therapies. RRx-001 is under investigation in a Phase 3 trial for the treatment of small cell lung cancer (SCLC), and in a Phase 2 trial for protection against oral mucositis in first line head and neck cancer. It is also under development as a medical countermeasure for nuclear and radiological emergencies and as a treatment for neurodegenerative diseases like Parkinson’s and ALS/MND.
About EpicentRx, Inc.
EpicentRx is a leading-edge clinical-stage biopharmaceutical company with a complementary pipeline of small molecules, novel drug delivery devices, and cancer selective virus platforms that target inflammatory diseases of significant unmet need. For more information, visit www.epicentrx.com.