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

主题名称：低资源环境下的癌症治疗技术项目名称：PRV311：一种独立、安全、有效且经济实惠的治疗方法

• 批准号: 10699948
• 负责人: MANIJEH GOLDBERG
• 金额: $ 204.99万
• 依托单位: PRIVO TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10699948
• 关键词: Cancer Etiology; Case Report Form; Cervix Neoplasms; Cessation of life; Clinical; Clinical Trials; Collaborations; Contracts; Country; Goals; Health Personnel; Healthcare; High Prevalence; Infrastructure; Institutional Review Boards; Letters; Logistics; Malignant neoplasm of cervix uteri; Pharmaceutical Preparations; Phase; Phase I/II Clinical Trial; Preparation; Prevention; Qualifying; Resource-limited setting; Resources; Site; Technology; Woman; analytical method; cancer therapy; cost effective treatment; design; effective therapy; electronic data capture system; interest; low and middle-income countries; nanoengineering; nanoparticle; novel therapeutics; success

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.

宫颈癌（CC）在低收入和中等收入国家（LMICs）的患病率很高，并且仍然是妇女癌症死亡的主要原因，尽管在富裕国家的预防方面取得了显着进步。Privo Technologies打算通过PRV 311弥合这一医疗保健差距，PRV 311是一种纳米工程独立且具有成本效益的治疗方法，用于将化学负载纳米颗粒局部递送到宫颈肿瘤。PRV 311不需要特殊的基础设施或专家临床医生，使其在缺乏所述专业化的低资源地区可行。本项目的目标是完成临床试验准备活动，以在LMIC临床环境中验证PRV 311技术。这将需要开发和鉴定分析方法，临床试验的GMP生产，LMIC的生产优化，电子数据采集系统和病例报告表的设计以及其他任务。 鉴于I期类似活动的成功，Privo预测PRV 311将被临床验证为CC的有效治疗方法。该合同将支持1/2期临床试验的准备工作，随后将支持PRV 311的关键3期和新药申请。