#United States #Peabody #Privo Technologies #PRV111 #Oral Cancer

Privo Technologies Advances Cancer Treatment with PRV111

Privo Technologies, Inc., an innovator in localized cancer therapies, has recently reached a significant milestone in its clinical journey by successfully completing the enrollment phase in its ongoing Phase 2/3 clinical trial, dubbed CLN-004. This trial is centered around PRV111, a cutting-edge nano-engineered chemotherapy patch developed for the treatment of cancers found in the oral cavity, across various disease stages.

The conclusion of enrollment in Arm 1 of the Phase 2 run-in portion comes with great anticipation. The data generated from this phase is under examination and will be submitted to the U.S. Food and Drug Administration (FDA) as part of the preparation for progressing into the more extensive Phase 3 study. This step marks a crucial progression in Privo's overarching mission: to enhance patient outcomes and alleviate the need for invasive surgical procedures.

Promising Early Results

While detailed results are still pending, initial observations from the Phase 2 run-in have provided hope with positive indications regarding safety and local tumor responses. Remarkably, no systemic toxicity has been reported among those patients who exhibited favorable local responses to PRV111. In some cases, surgical interventions were deemed unnecessary, based on the lack of detectable disease following the treatment with PRV111. Such findings inspire confidence in PRV111's potential to revolutionize treatment by offering a localized, tissue-sparing method for patients suffering from early-stage oral lesions.

This alignment with Privo’s commitment to advancing localized cancer treatments is crucial, as it emphasizes reducing the requirement for the traditional invasive approach while enhancing the patients' quality of life significantly. Privo extends its sincere gratitude to the clinical staff, investigators, and patients whose efforts contributed to this promising milestone.

The CLN-004 Trial Explained

The CLN-004 study itself is an adaptive, open-label Phase 2/3 investigation designed to evaluate the safety and preliminary efficacy of PRV111 in treating localized oral cavity lesions. During the Phase 2 run-in, patients were treated with PRV111 as a standalone therapy targeting oral carcinoma in situ and high-grade oral dysplasia.

A primary goal of this stage is to ascertain whether PRV111's localized delivery can safely and effectively eradicate pre-cancerous and early-stage cancerous lesions, thereby minimizing the reliance on surgical interventions. This completion signifies not just an advancement in clinical milestones but also a crucial step toward realizing the broader goal of patient-centered cancer care.

Dr. Manijeh Goldberg, CEO of Privo Technologies, reflected on this achievement, stating, “Completing enrollment in the Phase 2 segment of our study is a pivotal moment for Privo and our collaborators in clinical research. The promising initial observations set a solid foundation as we prepare to present our findings to the FDA for the next trial phase.”

PRV111’s Innovative Technology

PRV111 operates as part of Privo’s proprietary PRV platform, a series of nano-engineered drug delivery systems focusing on delivering concentrated doses of chemotherapy directly to tumor sites while mitigating systemic exposure. The design of PRV111 as a topical, transmucosal patch allows it to attach to oral lesions precisely, ensuring the direct delivery of chemotherapeutic agents like cisplatin nanoparticles through the mucosal membranes into the affected areas.

Each application of PRV111 is uniquely tailored to the tumor’s size and shape, ensuring accurate coverage and consistent drug delivery across diverse anatomical surfaces. This localized approach not only diminishes systemic toxicity—commonly associated with traditional chemotherapy—but also preserves adjacent healthy tissues vital for the patient’s overall functioning. By potentially sidestepping extensive surgical excisions, PRV111 looks to uphold normal functions such as speech and swallowing, which are often compromised through standard treatments.

The ongoing CLN-004 trial builds on Privo's previous experiences and successes with PRV111 in earlier clinical frameworks. Notably, findings from the CLN-001 trial revealed encouraging tumor responses without any systemic side effects, underscoring the innovative fabric of localized cancer treatment.

Future Prospects

With the Phase 2 enrollment behind them, Privo Technologies is poised for the next significant leap, planning to submit the dataset from the CLN-004 study to the FDA. This data will be crucial in designing the pivotal Phase 3 trial aimed at further validating PRV111 as a localized, non-surgical treatment alternative.

Dr. Goldberg concluded, “This milestone brings us one step closer to delivering solutions that minimize the profound impacts of major surgical processes on patients’ lives. Our ongoing commitment remains towards localized, patient-focused cancer care that strives to elevate patient outcomes while preserving essential aspects of their quality of life.”

About Privo Technologies

Founded with a vision to redefine cancer treatment paradigms, Privo Technologies specializes in localized drug delivery systems that maximize chemotherapy efficacy while significantly reducing collateral systemic effects. Based in Peabody, Massachusetts, Privo is at the forefront of developing patient-centric therapies designed to improve treatment outcomes and uphold quality of life for individuals battling solid tumors. For more information, visit www.privotechnologies.com.