Privo Technologies announced that its intraoperative cisplatin patch, PRV211, met the primary safety endpoint in Arm 2 of the Phase 2/3 CLN-004 trial for patients with invasive oral cavity cancer. In the earlier phase 1/2 group of eight patients, no treatment-related serious adverse events, systemic toxicities, or dose-limiting toxicities were observed, and wound healing was not delayed.
Pharmacokinetic results showed that cisplatin exposure in the bloodstream was negligible, indicating the drug stays localized at the surgical site and minimizes effects on the rest of the body. This supports the patch’s goal of delivering chemotherapy directly where the tumor was removed.
Enrollment for Arm 2 of the study is now complete, and patients will be followed for 12 months to assess local and regional cancer recurrence. PRV211 is a sterile, nanoengineered patch applied to the tumor bed for 10 to 20 minutes immediately after surgery, designed to improve local cancer control while reducing systemic side effects.