Deliver chemotherapy (cisplatin) directly to the tumor site!
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Deliver chemotherapy (cisplatin) directly to the tumor site! The new local drug delivery system PRV111 has a significant effect on the treatment of early stage head and neck cancer (HNSCC) stage 1/2!
PRV111 is an innovative transmucosal drug delivery system. It is a local patch that is placed directly on the tumor site, making the level of cisplatin in the tumor 350 times that of standard intravenous treatment.
Head and neck cancer (Image source: Medgadget)
Privo Technologies is a biopharmaceutical company dedicated to the development of innovative therapies to treat disabling and potentially lethal mucosal cancer. Recently, the company announced the positive results of a Phase 1/2 clinical trial evaluating the pilot asset PRV111 for the treatment of patients with early head and neck squamous cell carcinoma (HNSCC) . PRV111 is an innovative transmucosal drug delivery system that can locally deliver cisplatin (cisplatin) directly to the tumor site. The data from the trial supports the company’s expected mission since its establishment, which is to optimize the most advanced chemotherapy drugs to make them “more effective for cancer and easier for patients.”
PRV111 is a local patch designed to deliver and retain high concentrations of the chemotherapy drug cisplatin in the primary tumor and related lymph nodes.
When placed on a tumor, PRV111 releases and retains cisplatin-loaded nanoparticles in the tumor , resulting in a significant reduction in tumor volume and an increase in tumor- infiltrating lymphocyte levels without the systemic associated with intravenous cisplatin Side effects (ie nephrotoxicity and neurotoxicity).
The primary endpoint of the study is to determine the safe and effective dose of PRV111 based on the incidence of dose-limiting toxicity (DLT) and the change in tumor volume compared with baseline. PRV111 is associated with observable tumor volume reduction of 35-100% (average 69%) .
The secondary endpoint is to evaluate the tumor response and platinum levels in the whole body, tumor and lymph nodes after the administration of PRV111.
The overall tumor response rate of the evaluable subjects was 87.5% , and the average time from treatment to response was 5.5 days.
Among the subjects who completed the 6-month follow-up, 100% did not observe local recurrence, and tumor infiltrating lymphocytes increased after treatment .
PRV111 has good safety and no serious adverse events (SAE). The severity of the reported treatment-period adverse events (TEAE) was mild or moderate, and no dose-limiting toxicity (DLT) was observed. PRV111 treatment resulted in cisplatin levels in tumors 350 times higher than standard cisplatin IV therapy, 110 times higher in lymph nodes than standard cisplatin IV therapy, and 700 times lower in blood than standard cisplatin IV therapy. No reported cases of systemic toxicity were observed.
Following the post-phase 2 meeting with the US FDA , Privo is working to establish the key elements of the Phase 3 project to support the new drug application (NDA) for the treatment of early head and neck squamous cell carcinoma (HNSCC) in the oral cavity.
The results of these clinical trials have clinically verified Privo’s transmucosal drug delivery system.
At present, the company is also committed to further developing the PRV111 platform for a series of mucosal cancers, including anal cancer, colorectal cancer, urogenital cancer, nasal cancer and skin cancer, and exploring the role of PRV111 in the treatment of oral precancerous lesions. application.
Privo’s initial focus is on oral cancer, and its two lead assets are PRV111 and PRV211.
PRV111 is a derivative product of the PRV platform. This is a new nanotechnology- based system that can improve the efficacy of powerful anti-cancer drugs and significantly improve their safety through local regional administration.
This method eliminates needles, avoids stomach acid, significantly reduces the side effects of the drug, and allows the dose to be increased where the drug is most effective-all of which have the potential to improve patient prognosis and compliance.
The PRV platform has a wide range of potential applications and can be used for other mucosal cancers, including anal cancer, colorectal cancer, urogenital cancer, nose cancer, and skin cancer.
Another derivative product, PRV211, is a sterile, fast-release chemotherapy patch that can be used during surgery after tumor resection to potentially reduce the risk of cancer recurrence.
Reference：
Privo Technologies Announces Positive Results From Phase 1/2 Clinical Trial for PRV111 in Head and Neck Squamous Cell Carcinoma
Deliver chemotherapy (cisplatin) directly to the tumor site!
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