Privo Technologies Inc. is committed to advancing cancer treatment through innovative nanotechnology-based formulations. We are currently conducting a clinical study to evaluate the safety, efficacy, and tolerability of two of our products: PRV111 and PRV211.

CLN-004:  Study Details | Safety and Efficacy Study of PRV211 in Subjects With Oral Squamous Cell Carcinoma | ClinicalTrials.gov

Study Overview:
The CLN-004 clinical study is a Phase 1/2, open-label, two-arm study designed to assess the safety, efficacy, and tolerability of PRV111 (Cisplatin Transmucosal System) and PRV211 (Intraoperative Cisplatin System) in subjects amenable to surgery.

Products Being Tested:

• PRV111:  Topical locoregional delivery of cisplatin nanoparticles placed over the tumor region targeting patient population with Carcinoma in Situ (CIS) of the lip or oral cavity amenable to surgery. PRV111 is intended as a local induction chemotherapy, to improve the local control of the disease and eliminate or reduce the extent of the surgery to preserve form and function in the oral cavity.
• PRV211:   PRV211 is a nanoengineered delivery system intended for intraoperative chemotherapy treatment for all solid tumor surgeries immediately following surgical excision. The goal is to treat the tumor bed locally, eliminating any remaining micrometastases or close margins that are unable to be fully resected while avoiding system circulation.

Study Arms and Subject Assignment: Participants will be assigned to one of two study arms based on their disease staging:

• Arm 1: Subjects with pathologically proven and clinically confirmed Tis/CIS (carcinoma in situ) of the lip or oral cavity.
• Arm 2: Subjects with pathologically proven and clinically confirmed T1-T3, Nx, M0 (stages 1 to 3, no nodal metastasis, no distant metastasis) of the lip or oral cavity.

Phase 3 Preparation: Following the recruitment and analysis of Phase 2 subjects, Arm 1 of the CLN-004 study will transition into a Phase 2/3 lead-in study. Privo is actively preparing for the Phase 3 portion of this clinical study, demonstrating our commitment to advancing this promising treatment towards regulatory approval.

For more detailed information about our previous Phase 2 trial, please visit this link.