PRV111 Meets Primary Efficacy Endpoint in Ongoing Phase 2/3 Trial
Key Highlights:
92% complete response (CR) rate: Eleven of twelve evaluable patients achieved a centrally confirmed pathologic CR following a single cycle of PRV111; the remaining patient was down-staged from high-grade to low-grade dysplasia.
All patients avoided surgery: PRV111 cleared or downgraded lesions without the need for surgical excision. Treated mucosa healed completely, with normal appearance and no scarring.
Durable responses: Patients continue to be monitored. As of now, no recurrences have been observed, with a median follow-up of about 6 months and responses about 12 months in the longest-treated patient.
Well-tolerated: Systemic cisplatin exposure remained negligible; 85% of treatment-related adverse events were mild, and none were serious.
PRV111, developed by Privo Technologies, shows promising results as a non-surgical therapy for early-stage non-invasive oral cancer and high-grade dysplasia. In the ongoing CLN-004 Phase 2/3 trial, the treatment achieved an impressive pathologic complete response rate of 92%. Notably, all patients treated with PRV111 avoided the need for surgical intervention, a groundbreaking development for a condition that often necessitates multiple excisions.
Dr. Manijeh Goldberg, the Founder and CEO of Privo Technologies, emphasized the significance of these results. "The complete response rate achieved with PRV111 is among the highest reported for localized therapies in this setting. Patients typically face repeated surgical resections, which can lead to adverse effects like fibrosis and scarring, impacting their functionality. This non-surgical patch not only cleared the tumors but aided in preserving the native tissue function. These results showcase PRV111's potential to redefine the standard of care for oral precancer and early carcinoma in situ. We are one step closer to offering patients a non-surgical alternative to traditional surgical procedures," stated Dr. Goldberg.
The CLN-004 study builds on Privo's previous findings from the first-in-human trial (CLN-001), where PRV111 demonstrated significant local tumor responses without causing systemic toxicity. Initial results have supported the case for PRV111's effectiveness, as seen in publications that highlight its innovative approach in localized cancer treatment.
Detailed Results: In the recent CLN-004 trial, twelve patients diagnosed with non-invasive oral cancers or high-grade dysplasia underwent treatment with a single cycle of PRV111. Out of these, eleven patients were confirmed to have achieved a complete pathologic response. The twelfth patient showed a positive change, being downstaged to low-grade dysplasia. Remarkably, treatment resulted in resolution of all lesions, allowing mucosal surfaces to regenerate without any scarring or distortion. After a median follow-up of about six months, there have been no recurrences noted, with some patients maintaining responses beyond six months and one patient up to twelve months. Significantly, there were no severe treatment-related adverse effects, reinforcing the treatment's favorable safety profile.
Transforming the Treatment Paradigm: The management of non-invasive oral cancer and high-grade dysplasia has traditionally relied on surgical excision. However, this method is often associated with high recurrence rates and other complications. PRV111 offers a revolutionary approach by delivering concentrated doses of cisplatin directly into affected areas during a short, office-based procedure. This focused delivery minimizes the systemic effects typically linked with conventional chemotherapy, marking a significant advancement in treatment options for these conditions.
Next Steps: Following the success of the current trials, Privo Technologies is preparing to launch a registrational study for PRV111 directed at non-invasive oral cancers and high-grade dysplasias. The company is also looking to explore the use of PRV111 in other early malignant and premalignant lesions, highlighting the broader potential for non-surgical treatment alternatives.
About PRV111: PRV111 is a nanoengineered topical patch engineered to deliver high doses of cisplatin directly into oral lesions and surrounding mucosa, all while limiting systemic exposure. The design ensures the patch adheres effectively to the lesion, facilitating rapid drug absorption into dysplastic tissues, after which it is simply removed.
About Privo Technologies: As a late-stage clinical biopharmaceutical company, Privo Technologies is at the forefront of developing localized, minimally invasive therapies for solid tumors, leveraging a unique nanoengineered delivery platform. The organization's primary focus is to innovate patient-centric therapies that enhance treatment outcomes and preserve the quality of life for individuals battling solid tumors.
Frequently Asked Questions
What is PRV111 and what conditions does it treat?
PRV111 is a nanoengineered patch designed to treat early-stage non-invasive oral cancer and high-grade dysplasia.
How effective is PRV111 based on the recent trial?
The trial reported a remarkable 92% complete response rate, with all patients avoiding surgery.
What are the benefits of using PRV111 over traditional methods?
PRV111 offers a non-surgical solution that reduces the risk of complications associated with surgery and minimizes systemic side effects.
Are there any side effects associated with PRV111?
In the trial, treatment-related adverse events were mostly mild, with no serious side effects reported.
What are the company's future plans for PRV111?
Privo Technologies plans to initiate further registrational studies and explore additional applications for PRV111.
