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The primary endpoint of the study was to determine the safe and effective dose of PRV111 based on the incidence of dose-limiting toxicity (DLT) and the change in tumor volume from baseline
PRV111 has good safety and no serious adverse events (SAE)
Following the Phase 2 post-meeting with the US FDA, Privo is working to establish key elements of the Phase 3 project to support the New Drug Application (NDA) for the treatment of early oral head and neck squamous cell carcinoma (HNSCC)
The results of these clinical trials have clinically validated Privo's transmucosal drug delivery system
Privo’s initial focus is on oral cancer, and its two main assets are PRV111 and PRV211
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
Original source: Privo Technologies Announces Positive Results From Phase 1/2 Clinical Trial for PRV111 in Head and Neck Squamous Cell Carcinoma
(Source: Internet, reference only)
