On October 14, 2025 Privo Technologies, Inc. a leader in localized cancer therapies, reported the completion of enrollment in Arm 1 of the Phase 2 run-in portion of its ongoing Phase 2/3 clinical trial (CLN-004) evaluating PRV111, a nano-engineered chemotherapy patch designed to treat oral cavity cancers across distinct stages of disease (Press release, Privo Technologies, OCT 14, 2025, View Source [SID1234656645]).
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The Phase 2 run-in data are currently being analyzed for submission to the U.S. Food and Drug Administration (FDA) prior to continuing enrollment in the Phase 3 portion of the study.While detailed results remain under review, initial observations from the Phase 2 run-in are highly encouraging with respect to both safety and local tumor response with no evidence of systemic toxicity and among patients who demonstrated a favorable local response. Investigators determined that planned surgical procedures could be cancelled based on the absence of visible or measurable disease following PRV111 treatment. These findings suggest that PRV111 has the potential to offer a localized, tissue-sparing approach for early-stage oral lesions, subject to further clinical evaluation and regulatory review.
These early results support Privo’s mission to advance targeted, localized cancer therapies aimed at reducing the need for invasive procedures and improving patients’ quality of life.
Privo extends its gratitude to the investigators, clinical staff, and patients who made this milestone possible.
About the CLN-004 Phase 2/3 Clinical Trial
CLN-004 is an adaptive, open-label Phase 2/3 clinical study evaluating the safety, tolerability, and preliminary efficacy of PRV111 for the localized treatment of oral cavity lesions.
In the Phase 2 run-in (Arm 1), enrolled patients were treated with PRV111 as a stand-alone, non-surgical topical therapy for oral carcinoma in situ (CIS)/ high-grade oral dysplasia (HGD). The goal of this stage is to determine whether localized delivery of PRV111 can safely and effectively eliminate pre-cancerous and early-stage cancerous lesions while minimizing the need for surgery.
Completion of the Phase 2 enrollment marks an important milestone in Privo’s mission to develop therapies that spare patients from invasive surgery and potentially reduce recurrence risk.
"Completing enrollment in the Phase 2 portion of the CLN-004 study is a pivotal achievement for Privo and our clinical partners," said Dr. Manijeh Goldberg, Chief Executive Officer of Privo Technologies. "The initial observations are encouraging, and we look forward to sharing the full dataset with the FDA as we prepare for the Phase 3 evaluation. PRV111 reflects our vision to transform oral cancer treatment through precise, localized therapies designed to preserve function and quality of life."
Transforming Oral Cancer Treatment Through Localized Delivery
PRV111 is part of Privo’s proprietary PRV platform, a family of nano-engineered drug-delivery systems designed to deliver high concentrations of chemotherapy directly to tumor tissue while minimizing systemic exposure.
PRV111 is a topical, transmucosal patch that adheres directly to oral lesions, enabling the delivery of cisplatin nanoparticles through the mucosa to achieve targeted, localized drug penetration. Each PRV111 application is customized to the size and shape of the patient’s tumor, allowing precise coverage of the affected area and consistent drug delivery across complex anatomical surfaces.
This non-invasive, localized approach is intended to reduce systemic toxicity compared to conventional chemotherapy and to preserve surrounding healthy tissue. By potentially avoiding extensive surgical excision, PRV111 aims to help patients maintain normal speech, swallowing, and appearance—functions often affected by standard treatment options.
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.
Looking Ahead
With Phase 2 enrollment complete, Privo Technologies is preparing to submit the CLN-004 dataset to the U.S. FDA. The data from this phase will help inform the design of the pivotal Phase 3 trial, which is planned to further evaluate PRV111 as a localized, non-surgical treatment approach.
"This milestone moves us another step toward providing patients with treatments designed to minimize the life-altering consequences of major surgery," said Dr. Manijeh Goldberg, Chief Executive Officer of Privo Technologies. "Our platform continues to demonstrate the promise of localized, patient-focused cancer care that aims to improve outcomes while preserving quality of life."