Thus far, no method has been developed or authorized by the FDA (Food and Drug Administration) for reducing oral mucositis in patients suffering from head and neck cancer. To change that, EpicentRx – biopharmaceutical firm that uses innovative research to treat inflammatory-driven illnesses – has provided a more in-depth look at the phase 2 data that convinced the company to advance the research further in the clinic.
Most people who have chemoradiation treatment for head and neck cancer experience severe oral mucositis, which makes it difficult to eat, drink, and swallow. To combat this toxicity, EpicentRx has found RRx-001, a chemical that activates the anti-oxidative molecule called Nrf2 and suppresses inflammation through the NLRP3 inflammasome.
NLRP3 inhibitor RRx-001 restores tumor sensitivity to treatment by normalizing blood vessel function and reorienting tumor-associated macrophages. Small cell lung cancer (SCLC) is being studied in a Phase 3 trial with RRx-001, while oral mucositis in first-line head and neck cancer is being studied in a Phase 2 trial.
In addition to its use as a treatment for neurodegenerative disorders like Parkinson’s and ALS/MND, this inhibitor is also being developed as a medical form of defense for nuclear and radiation situations.
In June, EpicentRx gave researchers and interested parties a sneak peek at the results of the trial’s second phase. Now, the company has fleshed out the June data release by sharing more information about the efficacy of the various RRx-001 regimens and a glimpse at secondary outcomes.
Researchers who participated in the PREVLAR stage 2a clinical study reported the findings of their research in the International Journal of Radiation Oncology, Biology, and Physics. The study compared the efficacy of three different treatment regimens for the medication candidate among 53 patients. In one RRx-001 group, the median length of acute oral mucositis was 8.5 days, but in the control group, it lasted for 24 days. The other RRx-001 groups lasted either 10 or 17 days.
In addition to its numerical superiority over placebo, RRx-001 also excelled in a variety of qualitative metrics. The most effective RRx-001 arm reduced the severity of oral mucositis by half, with patients experiencing symptoms for only five days on average, versus 18 days in the control group.
The testing of the hypotheses on the efficacy endpoints was done “for exploratory purposes only.” The authors of the study were forthright about the constraints of the clinical trial. They mentioned that “the small patient cohorts and an open-label design…create significant limits on the interpretability of the results.”
EpicentRx wants to perform a bigger, randomized phase 2 study to acquire more information regarding the use of RRx-001 in the treatment of oral mucositis. These plans are based on the data that has been collected thus far.
RRx-001 has already moved into the phase 3 testing phase. Currently, the company is examining the effect on the survivability of pairing the experimental candidate with chemotherapy in patients who have been extensively pretreated for small-cell lung cancer.