TOPIC TITLE: CANCER TREATMENT TECHNOLOGIES FOR LOW-RESOURCE SETTINGSPROJECT TITLE: PRV311: A STANDALONE, SAFE, EFFECTIVE, AND AFFORDABLE TREATMENT FO

子宫颈癌在低收入和中等收入国家发病率很高，仍然是妇女癌症死亡的主要原因，尽管较富裕国家在预防方面取得了显著进展。Privo Technologies打算用PRV311来弥补这一医疗缺口。PRV311是一种纳米工程的、独立的、具有成本效益的治疗方法，用于向宫颈肿瘤局部递送载药纳米颗粒。PRV311不需要特殊的基础设施或专家临床医生，使其在缺乏专业化的低资源地区可行。该项目的目标是完成临床试验准备活动，以便在LMIC临床环境中验证PRV311技术。这将需要开发和鉴定分析方法、临床试验的GMP制造、中低收入国家的制造优化、电子数据捕获系统和病例报告表格的设计以及其他任务。鉴于i期活动的成功，Privo预计PRV311将作为一种有效的治疗CC的临床验证，该合同将支持准备1/2期临床试验，随后将支持PRV311的关键3期和新药申请。

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.