Massachusetts-based Privo Technologies reported that all 22 evaluable patients avoided planned surgery after receiving PRV111, its topical cisplatin patch, in Cohort 1 of the Phase II CLN-004 trial for non-invasive oral cancer or high-grade dysplasia.
Following a single treatment cycle, 21 patients achieved a centrally confirmed pathologic complete response, a rate of 95.5%. The remaining patient was downstaged from oral carcinoma in situ to low-grade dysplasia. No recurrences were observed at a median follow-up of 14 months, with the longest ongoing response exceeding 21 months.
PRV111 is a nanoengineered polymeric patch designed to deliver high doses of cisplatin directly into oral lesions while limiting systemic exposure. Privo reported negligible systemic cisplatin exposure and no systemic or dose-limiting toxicities. Of treatment-related adverse events, 85% were mild and none were serious.