Dual anti-cancer and radio/chemoprotective agent reduces toxicity from radiation exposure
Torrey Pines, Calif., December 6, 2022 – EpicentRx Inc. (“EpicentRx”), a leading-edge, clinical stage biopharmaceutical company that uses groundbreaking science to treat cancer and inflammatory-driven diseases, announced today that the U.S. Patent and Trademark Office has issued Patent No. 11,510,901 with claims covering its dual anticancer and radio/chemoprotective investigational agent, RRx-001, for the reduction of toxicity prior to, during, or after exposure to radiation from anticancer therapy or nuclear incidents. EpicentRx has also filed additional patent applications for the use of RRx-001 as a radioprotector and a chemoprotector.
The potential of RRx-001 as a radiation protection agent is related to evidence of NLRP3 inflammasome inhibition and Nrf2 activation, reducing the toxicity of radiation through the suppression of inflammation, free radical and oxidative stress. These protective effects of RRx-001 have also been seen in combination with chemotherapy such as alkylating and platinum compound agents.
EpicentRx recently completed a Phase 2 pilot study named PREVLAR (NCT03515538) which evaluated RRx-001 in head and neck cancer for protection against radiation-induced oral mucositis. Final analysis has been completed showing favorable results and a study manuscript is pending peer-reviewed publication. A larger Phase 2b randomized study named KEVLAR is being planned for further clinical evaluation of oral mucositis prevention.
In addition, studies are underway to develop RRx-001 as a so-called countermeasure under the U.S. Food and Drug Administration’s Animal Efficacy Rule for Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure resulting from a nuclear or radiological weapon, or from a nuclear accident. The Animal Rule approval pathway requires demonstration of efficacy in representative animal models. RRx-001 was granted orphan drug designation by FDA for ARS in 2020.
“This issued patent and other filed patent applications demonstrate our commitment to develop RRx-001, currently in a Phase 3 trial for the treatment of cancer, as a radioprotector, which is important not only to reduce side effects from radiation therapy in many different types of cancer but also in the case of a nuclear war or another Chernobyl accident,” said Tony R. Reid, M.D., Ph.D., Chief Executive Officer of EpicentRx.
RRx-001 is a first-in-class investigational agent with potential to reduce the harmful and debilitating side effects of effective yet toxic treatments like radiotherapy and chemotherapy. The two-stage mechanism of action has also shown anticancer benefit when combined with other treatments and is currently being evaluated with platinum-based chemotherapy in a Phase 3 study for small cell lung cancer.
About EpicentRx, Inc.
EpicentRx is a leading-edge 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.