PRV111 Shows Strong Responses in Early Oral Cancer

PRV111 demonstrated a high rate of pathologic complete responses (pCR) in patients with noninvasive oral cancer and high-grade dysplasia in the ongoing phase 2 CLN-004 trial (NCT05893888), with responses remaining durable during follow-up.¹

Updated results from cohort 1 of the trial showed a centrally confirmed pCR in 21 of 22 evaluable patients, for a pCR rate of 95.5%. The remaining patient was downstaged from oral carcinoma in situ (CIS) to low-grade dysplasia. All 22 patients avoided the planned standard-of-care surgical excision following treatment with PRV111.

"Patients typically face repeated surgical resections, which can lead to scar formation, anatomic distortion and functional impairments that can permanently affect speech and swallowing,” Eric Lamarre, MD, chief of Head and Neck Surgical Oncology at Cleveland Clinic, stated in a news release. “This non-surgical patch not only cleared the disease but preserved native tissue function without causing significant scar formation. These results reinforce PRV111's potential to redefine the standard of care for oral carcinoma in situ and dysplasias. We are one step closer to providing patients with a non-surgical alternative to repeated operative procedures."

The updated results build on an earlier analysis of cohort 1, in which 11 of 12 evaluable patients achieved a centrally confirmed pCR. The remaining patient was downstaged from high-grade to low-grade dysplasia.

About PRV111

PRV111 is a nanoengineered, polymeric topical patch designed to deliver high-dose cisplatin directly into oral lesions and adjacent mucosa while minimizing systemic exposure. The patch adheres to the lesion, allowing cisplatin to permeate into dysplastic tissue and regional lymphatics before it is removed following treatment.

The localized approach is intended to provide high concentrations of cisplatin at the site of disease while limiting systemic exposure associated with conventional administration. According to the developer, PRV111 is administered as a brief outpatient procedure.

CLN-004 Study: Background and Design

CLN-004 is an adaptive, multicenter phase 2/3 study evaluating localized nanoengineered cisplatin therapies in patients with oral cavity and lung cancers.² The PRV111 arm is evaluating topical locoregional delivery in patients with pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity.

Cohort 1 included 22 patients with biopsy-confirmed noninvasive oral cancer or high-grade dysplasia. Patients received a single cycle of PRV111, with pCR defined as the absence of residual dysplastic cells in posttreatment punch biopsy specimens based on histopathologic assessment.

Additional Findings

At a median follow-up of approximately 14 months (range, 8-21), no recurrences had been observed in treated areas. Several patients maintained responses beyond 14 months, and the longest ongoing response exceeded 21 months.

All treated lesions resolved, and mucosal surfaces regenerated with a normal appearance without scarring or distortion. The updated findings also showed negligible systemic exposure to cisplatin. No systemic toxicities or dose-limiting toxicities were reported, while treatment-related adverse events were primarily mild and transient oral symptoms. Overall, 85% of treatment-related adverse events were mild, and none were serious.

REFERENCES

1. Clinical Update from the Ongoing Phase 2 Trial of PRV111, the First Non-Surgical Therapy in Development for Early-Stage Oral Cancer. News release. Privo Technologies. October 5, 2026. Accessed October 5, 2026. https://tinyurl.com/mrwydm9y

2. A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers. ClinicalTrials.gov. Updated April 23, 2026. Accessed October 5, 2026. https://clinicaltrials.gov/study/NCT05893888