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A phase 2 trial examining the use of small molecule immunomodulator EC-18 in patients with head and neck cancer experiencing chemoradiation-induced oral mucositis met its primary and secondary end points.
Investigators have announced positive results from a phase 2 CRIOM trial (NCT03200340) that utilized a novel, first-in-class, small molecule oral immunomodulator EC-18 in patients with head and neck cancer who are experiencing chemoradiation-induced oral mucositis (CRIOM), according to a press release from the therapy’s developer Enzychem Lifesciences.
During a short-term follow-up of 13.5 days, patients who were treated with EC-18 reported a reduction of severe oral mucositis (SOM) compared with the placebo arm. Additionally, patients taking EC-18 experienced a reduction in incidence of SOM through completion of radiation of 37.1% (65% vs 40.9%). Moreover, the incidence of SOM was reduced by 35.1% in the EC-18 arm vs the placebo arm (70% vs. 45.5%).
"Severe CRIOM affects almost 75% of patients being treated with concomitant chemoradiation for head and neck cancers with symptoms that are so severe that they challenge a patients’ ability to tolerate optimal treatment," Stephen Sonis, MD, a professor at Harvard School of Dental Medicine and key advisor for the United States phase 2 CRIOM study, said in a press release.
EC-18 was developed to help reduce the duration and likelihood of SOM in conjunction with concomitant chemoradiation for patients with cancers of the mouth, oropharynx, and hypopharynx.
Patients who were set to receive intensity-modulated radiation therapy with daily fraction of 2.0 Gy to 2.2 Gy with an overall cumulative dose between 60 Gy and 72 Gy were eligible for enrollment. Additionally, patients also needed to have radiation fields with at least 2 mucositis sites at risk, with plans to receive concomitant single agent chemotherapy with cisplatin either weekly or tri weekly.
A total of 24 patients were included in stage 1 of the study and were randomized to receive 1 of several doses of EC-18: 500 mg, 1000 mg, 2000 mg, or the placebo. In stage 2, 81 patients were randomized and received either the placebo or 2000 mg of EC-18 twice daily over 7 weeks.
No serious adverse effects (SAEs) were reported between either group. Additionally, no SAEs appeared to be related to EC-18. Moreover, safety was comparable across all study arms. AEs were primarily attributed to chemoradiation.
Investigators are currently conducting a 1-year follow-up for tumor outcomes with this agent. Due to the positive findings, Enzychem is planning to file for breakthrough therapy designation with the FDA later this year, as well as continuing to a phase 3 trial for EC-18.
Enzychem Lifesciences announces positive results for phase 2 U.S study of EC-18 in chemoradiation-induced oral mucositis. News Release. Enzychem Lifesciences. October 20, 2021. Accessed October 21, 2021. https://yhoo.it/30S0CkB