The CLN-004 study, conducted across four major U.S. hospitals, evaluated the efficacy of PRV111 in delivering cisplatin directly to lesions. Unlike traditional surgical excision, which often results in scarring or functional impairment of speech and swallowing, the patch-based therapy cleared or downgraded all lesions while allowing the mucosa to heal without distortion. Pathologic analysis confirmed the absence of residual dysplastic cells in 95.5% of the evaluable cohort.
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Privo Technologies Reports 95.5% Response Rate in Oral Cancer Trial
Twenty-one of twenty-two patients in a Phase 2 trial for early-stage oral cancer achieved a complete response after using PRV111, a novel nanoengineered patch. The treatment allowed every participant in the study to avoid invasive surgery, marking a potential shift in how clinicians manage non-invasive oral carcinoma and high-grade dysplasia.
Dr. Eric Lamarre, Chief of Head and Neck Surgical Oncology at Cleveland Clinic, noted that the results represent some of the highest response rates reported for localized therapies in this clinical setting. With a median follow-up of 14 months—and some responses extending beyond 21 months—researchers observed no recurrences among the participants. The treatment profile also proved favorable, with 85% of adverse events categorized as mild and no systemic toxicity reported, as the patch minimizes the patient's exposure to cisplatin compared to standard chemotherapy.
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