Privo Technologies Inc, a developer of localised cancer therapies, announced on Tuesday the completion of enrolment in Arm 1 of the Phase 2 run-in portion of its ongoing Phase 2/3 clinical trial (CLN-004) evaluating PRV111, a nano-engineered chemotherapy patch designed to treat oral cavity cancers across distinct stages of disease.

The Phase 2 run-in data are currently being analysed for submission to the US Food and Drug Administration (FDA) prior to continuing enrolment in the Phase 3 portion of the study.

While detailed results remain under review, the company reports that initial observations from the Phase 2 run-in are highly encouraging with respect to both safety and local tumour response, with no evidence of systemic toxicity and among patients who demonstrated a favourable local response. Investigators determined that planned surgical procedures could be cancelled based on the absence of visible or measurable disease following PRV111 treatment. These findings suggest that PRV111 has the potential to offer a localised, tissue-sparing approach for early-stage oral lesions, subject to further clinical evaluation and regulatory review.

Privo says that these early results support its mission to advance targeted, localised cancer therapies aimed at reducing the need for invasive procedures and improving patients' quality of life.

CLN-004 is an adaptive, open-label Phase 2/3 clinical study evaluating the safety, tolerability, and preliminary efficacy of PRV111 for the localised treatment of oral cavity lesions.

In the Phase 2 run-in (Arm 1), enrolled patients were treated with PRV111 as a stand-alone, non-surgical topical therapy for oral carcinoma in situ (CIS)/high-grade oral dysplasia (HGD). The goal of this stage is to determine whether localised delivery of PRV111 can safely and effectively eliminate pre-cancerous and early-stage cancerous lesions while minimising the need for surgery.

With Phase 2 enrolment complete, Privo Technologies is preparing to submit the CLN-004 dataset to the US FDA. The data from this phase will help inform the design of the pivotal Phase 3 trial, which is planned to further evaluate PRV111 as a localised, non-surgical treatment approach.