PRIVO TECHNOLOGIES, LLC — Department of Health and Human Services SBIR Phase II: 431

Description

Cervical cancer (CC) has a high prevalence in low- and middle-income countries (LMICs) and remains the leading cause of cancer deaths among women, despite the remarkable improvements in prevention seen in wealthier countries. Privo Technologies intends to bridge this healthcare gap with PRV311, a nanoengineered standalone and cost-effective treatment for localized delivery of chemo-loaded nanoparticles to cervical tumors. PRV311 does not require special infrastructure or expert clinicians, making it viable in low resource area lacking said specialization. The goal of this project is to complete clinical trial preparation activities in order to validate the PRV311 technology in an LMIC clinical setting. This will require developing and qualifying analytical methods, GMP manufacturing for clinical trial, manufacturing optimization for LMICs, design of electronic data capture systems and case report forms, and other tasks. Given the success of the Phase I-like activities, Privo predicts that PRV311 will be clinically validated as an effective treatment for CC. This contract will support preparation for a Phase 1/2 clinical trial, which will subsequently support a pivotal Phase 3 and new drug application for PRV311.