MOUNTAIN VIEW, Calif., Aug. 19, 2015 — EpicentRx, Inc., a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of potent, novel anti-cancer agents, announced today the publication of positive results from its Phase 1 clinical trial of RRx-001. The successful trial results were published today in the prestigious journal, Lancet Oncology.
The publication details the results of an open-label, single-arm trial Phase 1 trial conducted in 25 heavily treated adult patients with resistant solid tumors. The objectives of the study were to determine the safety, tolerability, and pharmacokinetics of RRx-001 in cancer.
The results of the trial demonstrated a remarkably good safety profile for RRx-001, which included no RRx-001-related serious adverse events or laboratory abnormalities at any tested dose. In addition, the data, which suggest that RRx-001 has anticancer, chemosensitization, and radiosensitization effects in multiple tumor types, supports further Phase 2 investigation of RRx-001. “What is striking about this study is the good tolerability of RRx-001 with the suggested improvement in both performance status and survival compared to historical controls,” said one of the co-investigators, Dr. Corey A. Carter, Chief of Thoracic Oncology at Walter Reed National Military Medical Center.
Dr. Gary Fanger, EpicentRx CEO said, “We are proud to have the results of the RRx-001 Phase 1 clinical trial published in Lancet Oncology and encourage everyone to read the article written by our Phase 1 Principal Investigator, Dr. Tony Reid from UCSD.” Epigenetic modifications underlie the promising clinical activity of RRx-001 across a wide range of cancer types, which includes the potential to change and reprogram the tumor microenvironment for resensitization to previously effective, yet refractory radiation and chemotherapy. These encouraging Phase 1 results set the stage for an ambitious Phase 2/3 development campaign in multiple refractory tumor types, including colorectal, primary GBM and lung, both alone and in combination with chemotherapy, immunotherapy and radiotherapy, to meet the diverse needs of oncology patients.
RRx-001 is a novel anticancer agent with a chemical structure most notable for the presence of twin nitro groups, which is unprecedented in clinical medicine. Its selective effect on blood flow in the hypoxic cancer tissue leads to a burst of “tumor-killing” reactive oxygen and nitrogen species that elicits a variety of anti-cancer effects. These effects, which include the modulation of multiple epigenetic enzymes, alter tumor multi-drug resistance mechanisms and “epi-sensitize” responses to anti-cancer agents including chemotherapy, checkpoint immunotherapy, and radiation. RRx-001 has completed a Phase 1 first-in-man clinical study, which demonstrated an excellent safety profile, and several Phase 2 trials are underway.
About EpicentRx, Inc.
Based in Mountain View, California, EpicentRx, Inc. is a clinical-stage biotechnology company advancing proprietary drugs that impact a variety of diseases and disorders particularly related to hematology and oncology applications. Funded by InterWest Partners, EpicentRx was formed as a cooperative partnership between Stanford University and the aerospace and defense contractor Orbital ATK. This was the first drug discovery program ever involving collaboration between a defense contractor, a life sciences company, a venture capital firm, and a university. The result led to the development of RRx-001, a Phase 2-stage compound with a novel epigenetic mechanism of action that has shown good safety and clinical activity in patients with cancer and has the ability to “epi-sensitize” patients which enhances drug combinatorial effects and resensitizes chemoresistant tumors to previously failed therapies. For more information about EpicentRx, Inc., please visit www.epicentrx.com
SOURCE EpicentRx, Inc.