On November 5, 2019 EpicentRx, Inc., a clinical cancer immunotherapy company targeting both sides of the immune system to deliver cancer treatments with minimal toxicity, reported that it has dosed the first patient in the Phase 3 REPLATINUM trial evaluating RRx-001 for the treatment of third-line and beyond small cell lung cancer (SCLC) (Press release, EpicentRx, NOV 5, 2019, View Source [SID1234550370]). REPLATINUM is EpicentRx’s first Phase 3 study of RRx-001, a small molecule immunotherapy targeting CD47 – SIRPα.

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Lung cancer is one of the most common cancers in the world, and the most common cause of cancer-related death. SCLC accounts for about 15% of all lung cancers, with a prevalence of over 300,000 patients globally. Almost 70% of SCLC patients present with extensive-stage disease at time of diagnosis and do not respond well to first- and second-line therapies due to the development of treatment resistance.

"The need for progress in third-line or beyond SCLC is clear, as the outcomes for these patients are uniformly fatal," said Corey A. Carter, M.D., President & CEO of EpicentRx and former head of thoracic oncology at Walter Reed Military Medical Center. "SCLC, especially SCLC in third-line or beyond, is dramatically underserved with ineffective options for patients."

REPLATINUM, an open-label, multicenter, crossover trial designed in collaboration with FDA, will evaluate the efficacy and safety of RRx-001 plus platinum doublet chemotherapy versus platinum doublet chemotherapy alone in 126 patients. REPLATINUM’s primary endpoint is progression-free survival, with overall survival and overall response rate as secondary endpoints.

The REPLATINUM trial follows positive results from EpicentRx’s ongoing Phase 2 QUADRUPLE THREAT trial, which is testing RRx-001 plus platinum chemotherapy in multiple cancer types, including SCLC. In patients with previously treated SCLC, RRx-001 plus platinum chemotherapy dramatically increased response rates, overall survival and progression-free survival compared to historical controls while suggesting a decrease in toxicities from chemotherapy. The QUADRUPLE THREAT data were recently published in the British Journal of Cancer.

"The strength of the Phase 2 trial allows us to keep REPLATINUM at a manageable size and should reduce the time and costs associated with a Phase 3 clinical trial. We are excited to have enrolled the first patient and look forward to working closely with our excellent clinical sites," said Dr. Carter.

RRx-001 has Orphan Drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma, and from EMA for SCLC.

About RRx-001

RRx-001 is a next generation small molecule immunotherapy being developed by EpicentRx. The therapy targets the CD47 – SIRPα axis and repolarizes tumor associated macrophages (TAMs) and other immunosuppressive cells in the tumor microenvironment to an immunostimulatory phenotype. RRx-001 stimulates the immune system and can be used as monotherapy or in combination with chemotherapy, immunotherapy, radiation and targeted agents, giving the therapy the potential to convert "treatment-resistant" tumors into "treatment-sensitive" tumors. RRx-001 is currently in the Phase 3 REPLATINUM trial for the treatment of third-line and beyond small cell lung cancer (SCLC). RRx-001 is also in the Phase 2 QUADRUPLE THREAT trial for the treatment of SCLC, non-small cell lung cancer, neuroendocrine tumors, ovarian and prostate cancer, and the Phase 2 PREVLAR trial for the prevention of oral mucositis. Clinical studies for the drug have also been conducted for the treatment of colorectal cancer, brain metastases and glioblastoma.