On October 22, 2021 Privo Technologies, Inc. ("Privo"), reported the positive results of their Phase 1/2 clinical trial examining their lead asset PRV111 in subjects with early-stage Head and Neck Squamous Cell Carcinoma (HNSCC). PRV111 is an innovative transmucosal delivery system capable of delivering cisplatin topically and directly to the tumor site (Press release, Privo Technologies, OCT 22, 2021, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-announces-positive-results-from-phase-1-2-clinical-trial-for-prv111-in-head-and-neck-squamous-cell-carcinoma [SID1234591884]). The data from the trial supports the Company’s intended mission since its inception of optimizing state-of-the-art chemotherapeutic drugs to be "Tough on cancer, Easy on patients".

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The primary endpoint of the study, which was to determine a safe and efficacious dose of PRV111 based on the incidence of dose-limiting toxicities (DLTs) and tumor volume changes from baseline, was met. PRV111 was associated with an observable tumor volume reduction of 35-100% (mean 69%). The secondary endpoints were to evaluate tumor responses and evaluate systemic, tumor and lymph node platinum levels following administration of PRV111. The overall tumor response rate in evaluable subjects was 87.5% with an average time to response of 5.5 days. No loco-regional recurrence was observed in 100% of subjects who completed a six-month follow-up. An increase in tumor-infiltrating lymphocytes was present post-treatment.

PRV111 showed a favorable safety profile with no severe adverse events (SAEs). Reported treatment emergent adverse events (TEAEs) were mild or moderate in severity, and no dose-limiting toxicities (DLTs) were observed. PRV111 treatment resulted in cisplatin levels that were found to be >350 times higher in the tumor, >110 times higher in lymph nodes, and >700 times lower in the blood than standard of care cisplatin IV treatments. No reported cases of systemic toxicity were observed.

The clinical trial design was Open-Label, Single-Arm Safety, Tolerability, Anti-Tumor Effects, Systemic Exposure, and Device Technical Effects of PRV111 in subjects with Head and Neck Squamous Cell Carcinoma. This was a two-stage, adaptive, first-in-human pharmacokinetic (PK), safety, and efficacy study. In Stage 1 and Stage 2, a total of 10 enrolled subjects were analyzed for safety and PK; eight of the 10 enrolled subjects were analyzed for efficacy.

Following an End-of-Phase 2 Meeting with the U.S. Food & Drug Administration (FDA), Privo is working on establishing the key elements of a Phase 3 program to support a New Drug Application (NDA) for the treatment of early-stage head and neck squamous cell carcinoma (HNSCC) of the oral cavity.

These clinical trial results have clinically validated the Privo’s transmucosal delivery system, and Privo is now also working to further develop PRV111 platform in a range of mucosal cancers including anal, colorectal, genitourinary, nasal and skin cancers and to explore the use of PRV111 for the treatment of precancerous oral cavity lesions.

About SCC

Squamous cell carcinoma (SCC) is cancer of the squamous cells – thin and flat cells that line the epithelia. SCC is found for the most part as a part of skin cancer, but SCC also accounts for the majority of oral, cervical, vaginal/vulval, and colorectal cancers. SCC in body cavities historically is associated with low survival rates and disfiguring surgeries, demonstrating a clear need for a better treatment. Privo focuses on SCC of the oral cavity as it is on the rise globally and lacks a clear treatment option for such a rare disease. Privo was granted Orphan Drug Designation for Treatment of anatomically accessible oral cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity) by the U.S. FDA.