Clinical Update from the Ongoing Phase 2 Trial of PRV111, the First Non-Surgical Therapy in Development for Early-Stage Oral Cancer

Key Highlights:

• 95.5% pathologic complete response (pCR) rate: Twenty-one (21) of twenty-two (22) evaluable patients achieved a centrally confirmed pathologic complete response following a single cycle of PRV111; the remaining patient was down staged from oral carcinoma in situ (CIS) to low-grade dysplasia.
• All patients avoided the planned standard-of-care surgery: PRV111 cleared or downgraded lesions without the need for surgical excision. Treated mucosa healed completely, with normal appearance and no scarring.
• Durable responses: Patients continue to be monitored. No recurrences have been observed, with a median follow-up of 14 months (8–21 months) since initiating treatment.
• Well-tolerated: Systemic cisplatin exposure remained negligible; 85% of treatment-related adverse events were mild, and none were serious.

BOSTON, Oct. 5, 2026 /PRNewswire/ -- Privo Technologies today announced results from the CLN-004 Phase 2 (Cohort 1) trial evaluating PRV111, a nanoengineered, cisplatin-releasing patch for the treatment of non-invasive oral cancer and high-grade dysplasia (HGD). These conditions are common, recur frequently, and typically require repeated surgical excision, which can impair speech, swallowing, and appearance.

The CLN-004 clinical study was conducted at four major U.S. hospitals known for treating head and neck cancers. PRV111 was studied in 22 patients and achieved a 95.5% pathologic complete response (pCR) rate, defined as the absence of any residual dysplastic cells in post-treatment punch biopsy specimens, as determined by histopathology. PRV111 also eliminated the need for standard-of-care surgery in 100% of patients and demonstrated durable local control, with no recurrence observed in the treated areas. Dr. Eric Lamarre, an investigator in the study and Chief of Head and Neck Surgical Oncology at Cleveland Clinic, commented:

"The complete response rate of 95.5% and the treatment durability achieved with PRV111 is among the highest reported for localized therapies in this setting. Patients typically face repeated surgical resections, which can lead to scar formation, anatomic distortion and functional impairments that can permanently affect speech and swallowing.  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 CLN-004 study builds upon Privo's earlier clinical experience with PRV111 (CLN-001), which showed promising local tumor responses with no systemic toxicity in a first-in-human setting. The results of that earlier trial were published in Nature Communications and highlighted by Forbes for their innovative approach to localized cancer drug delivery.

Detailed Results:

Twenty-two patients with biopsy-confirmed non-invasive oral cancer or high-grade dysplasia received a single cycle of PRV111. Twenty-one patients achieved centrally confirmed pathologic complete responses; the remaining patient was downstaged to low-grade dysplasia, eliminating the need for standard-of-care surgery. All treated lesions resolved, and mucosal surfaces regenerated without scarring or distortion. At a median follow-up of about 14 months, no recurrences were observed; several patients have maintained responses beyond 14 months, and the longest ongoing response is now greater than 21 months. No systemic toxicities or dose-limiting toxicities were reported. Treatment-related events were primarily mild, transient oral symptoms.

Transforming the Treatment Paradigm:

"We at Privo and the investigators in our CLN-004 study are excited by these encouraging results.   We are one step closer to providing patients with a non-surgical alternative to repeated operative procedures." said Manijeh Goldberg, PhD, MBA, CEO, President and Founder of Privo Technologies.

Current management of non-invasive oral cancer and HGD relies on surgical excision, which is associated with high recurrence rates and morbidity. PRV111 is designed to deliver high concentrations of cisplatin directly into dysplastic tissue through a brief, outpatient procedure, avoiding systemic side effects associated with traditional chemotherapy and standard-of-care surgery.

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, achieves rapid drug permeation into dysplastic tissue and regional lymphatics, and is removed after treatment.

About Privo Technologies:

Privo Technologies is a late-stage clinical biopharmaceutical company pioneering localized, minimally invasive therapies for solid tumors using its proprietary nanoengineered delivery platform. Privo is committed to developing innovative, patient-centric therapies that improve outcomes and preserve quality of life for patients with solid tumors.

To learn more, visit www.privotechnologies.com

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SOURCE Privo Technologies