Clinical Programs
First-in-Class: Changing the Standard of Care
PRV111 is a nano-engineered topical cisplatin patch designed to treat early-stage oral carcinoma in situ (CIS) and high-grade dysplasia (HGD) — without surgery. The current standard of care is wide local excision, which causes disfigurement, loss of function, and significant quality-of-life burden.
PRV111 delivers highly concentrated cisplatin directly to the lesion through the mucosa, clearing disease uniformly across the treated area while leaving healthy tissue intact — with no systemic toxicity observed across all trials.
Photographic Evidence of Efficacy — Lesion Clearance
Phase 2 results demonstrating PRV111's rapid and complete lesion clearance (Pre-Treatment Visit 1 vs. Post-Treatment Visit 5)
CLN-004 — Pre-Treatment (left) vs. Post-Treatment (right)
Photographic Evidence of Efficacy — High Grade Dysplasia Clearance
Phase 2 results demonstrating PRV111's rapid and complete high-grade dysplasia clearance
CLN-004 — Pre-Treatment (left) vs. Post-Treatment (right)
First-in-Class Intraoperative Chemotherapy
PRV211 is a sterile cisplatin patch applied directly to the tumor bed immediately following surgical resection. It addresses a critical clinical gap: microscopic cancer cells that remain at surgical margins and cannot be fully removed.
Post-surgical recurrence remains a significant challenge in head and neck cancer. PRV211's nanoengineered patch delivers localized chemotherapy precisely when tissue barriers are removed and access is optimal — with negligible systemic absorption.
Phase 1/2 Study Results — CLN-004 Arm 2
- Zero treatment-related serious adverse events — one reported mild burning sensation during healing only
- No systemic toxicities or dose-limiting toxicities across all 8 patients
- Normal wound healing with no surgical complications in any patient
- Negligible systemic absorption confirmed by pharmacokinetic analysis — validating targeted delivery
- Seamless integration into standard surgical procedures — no workflow disruption
- Patients enrolled with invasive tumors (T1–T4) requiring surgical excision, including advanced cases requiring reconstructive surgery
Next Steps
Patients will be monitored for efficacy outcomes including loco-regional recurrence at 12 months post-surgery. A future expansion study is planned to further evaluate PRV211's potential to reduce cancer recurrence across a broader range of solid tumor surgeries beyond head and neck cancer.
Targeted Intratumoral Cisplatin Therapy
PRV131 is a first-in-class cisplatin intratumoral injectable designed to deliver high concentrations of cisplatin directly into solid tumors while minimizing systemic exposure. It is supplied as a kit containing a lyophilized powder and a proprietary diluent, reconstituted immediately prior to use.
Once injected, PRV131 forms a localized drug depot within the tumor, enabling controlled release of cisplatin over time. The Phase 1/2 CLN-004 Arm 3 study is designed to identify a safe and effective dose for intratumoral treatment of oral cavity tumors (T1–T3, N0-1, M0).
Study Design
CLN-004 Arm 3 is a Phase 1/2 open-label study evaluating safety, tolerability, and preliminary efficacy of PRV131 in oral cavity cancer (T1–T3, N0-1, M0). The study is designed to identify a safe and effective dose, with expansion planned to lung cancer and other solid tumor indications. The first patient was dosed in December 2025.