What's Happening?
Privo Technologies has announced significant results from its CLN-004 Phase 2/3 trial evaluating PRV111, a nanoengineered, cisplatin-releasing patch for treating non-invasive oral cancer and high-grade
dysplasia. The trial reported a 92% complete response rate among twelve patients, with eleven achieving a centrally confirmed pathologic complete response following a single cycle of PRV111. The remaining patient was down-staged from high-grade to low-grade dysplasia. Notably, all patients avoided surgery, as PRV111 cleared or downgraded lesions without the need for surgical excision. The treated mucosa healed completely, with normal appearance and no scarring. The trial demonstrated durable local control, with no recurrences observed at a median follow-up of about six months, and responses lasting up to twelve months in the longest-treated patient. The treatment was well-tolerated, with 85% of adverse events being mild and none serious.
Why It's Important?
The development of PRV111 represents a potential paradigm shift in the treatment of non-invasive oral cancer and high-grade dysplasia, conditions that typically require repeated surgical excision. Surgery can lead to fibrosis, scar formation, and anatomic distortion, affecting speech and functionality. PRV111 offers a non-surgical alternative that preserves native tissue function, potentially redefining the standard of care for oral precancer and early carcinoma in situ. This advancement could significantly improve patient outcomes and quality of life by providing a less invasive treatment option that avoids the systemic side effects associated with traditional chemotherapy.
What's Next?
Privo Technologies plans to initiate a registrational study of PRV111 in non-invasive oral cancers and high-grade dysplasias. The company will also explore the application of PRV111 in other early malignant and premalignant lesions where non-surgical alternatives could provide significant benefits. This expansion could further establish PRV111 as a versatile treatment option across various types of cancerous and precancerous conditions.
