Molecule RRx-001 Receives Fast Track Designation From the FDA - EpicentRx

Tony Reid, MD, PhD and Bryan Oronsky, MD, PhD discuss Molecule RRx-001 Receives Fast Track Designation From the FDA


Molecule, RRx-001, has received fast track designation from the FDA. RRx-001 is a designer molecule with direct anti-inflammatory activity and is known to inhibit NLRP3, upgrade NRF2, and release nitric oxide, which has vascular dilating and anti-inflammatory properties. The FDA granted fast track designation based on the PREVLAR study, which showed a substantial reduction in oral mucositis, a severe side effect of chemotherapy and radiation, in head and neck cancer patients.


RRx-001 is unique in its ability to inhibit the inflammatory process through its direct and selective inhibition of NLRP3. This sets it apart from other therapies on the market, as it specifically targets and reduces inflammation in a fundamental way. By reducing toxicities associated with treatment, RRx-001 allows therapies to stay on schedule, potentially improving outcomes for cancer patients.


The development of RRx-001 molecule stemmed from the aerospace industry, as the company explored unconventional sources for new compounds. RRx-001 has undergone clinical trials, demonstrating its ability to affect vascular flow and bind to proteins critical in oncology development. The molecule has shown positive response rates and prolonged stable disease in various tumor types.


The next steps for RRx-001 molecule include a phase three trial for small cell lung cancer and further exploration of its potential in the treatment of severe oral mucositis and liver-predominant metastases. The company envisions RRx-001 fitting into the broader landscape of cancer treatment by combining multiple therapies to reduce toxicity and improve efficacy.


Challenges in bringing RRx-001 molecule to market include its uniqueness, which makes it difficult for regulatory agencies and potential partners to evaluate its potential. The company is actively promoting the molecule's dual properties and highlighting its ability to potentiate the activity of other agents while protecting against dose-limiting toxicities.


In addition to RRx-001, EpicentRx is working on a tumor-selective oncolytic antivirus that can neutralize TGFβ, a cytokine involved in immune suppression. The company sees these two platforms as complementary, with the potential to create effective combinations for cancer treatment.


EpicentRx aims to stay at the forefront of cancer treatment developments by actively participating in conferences, publishing manuscripts, and providing detailed descriptions of their drugs' mechanisms and properties. The company believes that the field of cancer treatment will continue to evolve, and they plan to leverage their innovative approaches to maintain a leading position in the industry.

Dr. Tony Reid, MD, PhD, Chief Executive Officer of EpicentRx.

Bryan Oronsky, MD, PhD, Chief Development Officer at EpicentRx.