Treatment with AG013 for prevention of oral mucositis did not show statistical significance of severe oral mucositis duration in patients with head and neck cancer undergoing chemoradiation in comparison with placebo, missing the primary end point of the phase II clinical trial, according to early topline results announced in a press release from Oragenics, Inc.
Treatment with AG013 for prevention of oral mucositis did not show statistical significance of severe oral mucositis duration in patients with head and neck cancer undergoing chemoradiation in comparison with placebo, missing the primary end point of the phase II clinical trial (NCT03234465), according to early topline results announced in a press release from Oragenics, Inc.
"We have now received the first cut of top line results for the study of AG013 in the prevention of oral mucositis in chemoradiation treatment of head and neck cancer,” Alan Joslyn, PhD, president and chief executive officer, Oragenics, said in a statement.1 “The results are equivocal in relation to the efficacy outcomes and we now await a more detailed ongoing analyses to determine if there may be potential efficacy for sub-patient populations, which we expect over the coming weeks."
The purpose of this multicenter, randomized, double-blind, placebo-controlled study was to evaluate the efficacy, safety, and tolerability of AG013, administered topically, in its ability to prevent oral mucositis in patients with head and neck cancer undergoing chemoradiation. Investigators measured AG013 from the start of chemoradiation until 2 weeks after completion by the duration, time to development, and overall incidence of oral mucositis during the active treatment phase among patients enrolled on the study.
Patients are randomized 1:1 to receive either AG013 or placebo
Other co-primary objectives in the study were the time to development as well as by overall incidence of oral mucositis during active treatment, and the safety and tolerability. Secondary end points include patient-reported symptoms, analgesic use, cumulative radiation dose prior the to onset of oral mucositis, biomarkers, and PK profile of AG013 in 2 defined subsets of patients.
To be eligible to enroll in this study, patients must have a tumor HPV status established, plans to receive either primary or post-operative chemoradiation, a planned intensity-modulated radiotherapy, and planned administration of cisplatin on a weekly or tri-weekly dosing schedule. Patients had to be at least 21 years or older to enter the study and have a Karnofsky performance score of ≥ 70%.
Patients cannot enroll in the study if they had previous radiation to the head and neck, an increased risk of developing infectious endocarditis, or previous gene therapy. They also could not have a present active infectious oral disease or any oral lesions that could confound the ability to assess the oral mucositis grade.
The study is being conducted at around 50 different sites in the United States, Belgium, Germany, and the United Kingdom under the direction of Joslyn. Two hundred patients are expected for enrollment. Accrual was initiated in July 2017, and the study is expected to be completed around March 2021.In December 2019, the company announced that the trial had completed enrollment of 200 patients.2
“Oral mucositis is a debilitating condition in head and neck cancer patients receiving chemoradiation and it is our belief that AG013 will provide relief for patients at risk for development of this condition and allow them to successfully complete their cancer treatment regimen,” Joslyn said.