- License partner SciClone Pharmaceuticals oversees trial in China.
- Phase 3 REPLATINUM multicenter clinical trial with over 50 sites in the U.S. and China is underway
Torrey Pines, Calif., Oct. 6, 2022 /PRNewswire/ – EpicentRx, a late clinical stage biopharmaceutical company with novel therapies to target cancer and inflammatory diseases, announced today the start of dosing in China for the global Phase 3 clinical trial REPLATINUM (NCT05566041) with partner SciClone Pharmaceuticals. The trial in the US and China is designed to compare the efficacy of RRx-001 and a first line platinum doublet versus a platinum doublet in approximately 300 third-line or beyond extensive stage SCLC patients that previously received a platinum doublet and a checkpoint inhibitor.
RRx-001, a tumor-activated small molecule that inhibits the NLRP3 inflammasome and repolarizes tumor associated macrophages (TAMs), is used to restore sensitivity to chemotherapy that has already been tried. The primary endpoints of the study are progression free survival (PFS) and overall survival (OS) in patients with third line and beyond extensive stage SCLC.
The goal is to evaluate the efficacy of platinum doublet rechallenge after treatment with RRx-001 in late line extensive stage SCLC, a stubbornly resistant cancer with a nearly one-hundred percent mortality rate. To date, RRx-001 has not been associated with any dose limiting toxicities either alone or in combination with chemotherapy.
“The deck is stacked against patients with SCLC, a highly aggressive and metastatic cancer. These patients are usually heavy smokers with underlying smoking-related issues such as chronic cardiovascular disease, end-stage renal failure, diabetes, and COPD. The best responses are seen in first line with platinum-based chemotherapy, but resistance develops quickly, and later line options are few and far between. RRx-001 is a chemosensitizer with the potential to help SCLC patients around the world by restoring sensitivity to first line platinum-based chemotherapy,” said Dr. Tony R. Reid, CEO of EpicentRx.
EpicentRx and SciClone Pharmaceuticals established a licensing agreement for RRx-001 in Greater China in 2020.
The Phase 3 trial follows the successful completion of the Phase 2 QUADRUPLE THREAT clinical trial (NCT02489903) of RRx-001 in late line SCLC patients, which achieved its primary endpoint, meeting the criteria to begin REPLATINUM.
RRx-001 is an only-in-class investigational NLRP3 inhibitor with dual anti-inflammatory and anticancer activity for the treatment of multiple conditions in oncology, gastroenterology, autoimmunity, and neurodegeneration. It impairs tumor growth in multiple cancer models, reprograms myeloid compartments, and reverses resistance to previously administered chemotherapy. Its dual mechanism of action—protection of normal tissues and toxicity to tumors—is related to the molecular fragmentation that occurs only in the interior of tumors, where tumor associated macrophages (TAMs) are located. Increased infiltration of TAMs, a sine qua non for the anticancer activity of RRx-001, has been observed in many tumors including SCLC. For more information on the Phase 3 trial, please visit https://clinicaltrials.gov/ct2/show/NCT05566041.
EpicentRx is a late clinical stage, dual platform biopharmaceutical company with a pipeline of first-in-class, small molecules, viruses, and next-generation devices that address multiple indications of significant unmet need including cancer, autoimmune and neurodegenerative diseases, and protection against toxicity from radiation and chemotherapy.