Highly focused loco-regional chemotherapy for oral cancer - IND 132234 - October 01 2017

口腔癌高度集中的局部化疗 - IND 132234 - 2017 年 10 月 1 日

• 批准号: 9807865
• 负责人: Manijeh N Goldberg
• 金额: $ 44.93万
• 依托单位: PRIVO TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9807865
• 关键词: Highly; focused; loco; regional; chemotherapy

Project Summary According to the National Cancer Institute, about 50,000 people in the US will be newly diagnosed with oral cancer (OC) in 2018, causing over 9,700 deaths. OC is a severely neglected orphan disease with a lack of significant treatment advances in 4 decades and about 64% of patients die within the first 5 years of diagnosis. Historically, OC has been present in heavy smokers and drinkers. However, more recently OC has also become more prevalent in younger people due to an increase in cancer-causing human papillomavirus (HPV) spread through oral sex. The current standard of care (SOC) for patients with early stage disease is surgical intervention. However, this can result in disfiguring side effects that impair oral form and function such as the ability to speak and swallow. Surgical treatment of OC also has an exceptionally high rate of recurrence, due in part to tumor margins which are difficult to identify or access. To address this unmet need, Privo Technologies has developed a topical chemotherapy patch, PRV111 that is applied directly to the tumor. PRV111 consists of a mucoadhesive polymeric patch with embedded cisplatin-loaded particles (CPs) and a non-permeable backing that facilitates unidirectional drug release, prevents drug loss, and masks taste. Cisplatin is recognized as the gold standard chemotherapeutic for treating oral cancer. However, cisplatin’s efficacy is often hindered by significant systemic toxicity resulting from traditional systemic intravenous (IV) administration. CP’s have optimized size, charge, and permeation parameters to ensure that cisplatin is locally retained within the tumor tissue and not exposed to systemic bodily circulation. Privo has performed 12 sets of in vivo studies in 5 species of animals to examine the safety and efficacy of PRV111. In all cases, PRV111 has shown robust antitumor effect and no local or systemic toxicities. The goal of this proposal is the successful completion of Privo’s clinical trial. The results of this study will be published to share its findings with the scientific and medical community. Privo is confident that its team of expert scientists, business leaders, and collaborators can execute its defined aims with milestones and deliverables.

项目概要 据美国国家癌症研究所称，美国将有约 50,000 人新诊断出患有口腔癌 (OC) 2018 年，OC 已导致 9,700 多人死亡，是一种严重被忽视的孤儿疾病，且治疗方法缺乏重大进展。 4 年来，约 64% 的患者在诊断后的前 5 年内死亡。历史上，OC 一直存在于重型患者中。 然而，最近，由于吸烟者和饮酒者的增加，OC 在年轻人中也变得更加普遍。 致癌的人乳头瘤病毒 (HPV) 通过口交传播 目前针对癌症患者的护理标准 (SOC)。 早期疾病是手术干预，但这可能会导致毁容的副作用，损害口腔形态和功能。 OC 的手术治疗也具有极高的复发率。 部分原因是肿瘤边缘难以识别或接近。 为了解决这一未满足的需求，Privo Technologies 开发了一种局部化疗贴剂 PRV111，应用于 PRV111 由粘膜粘附聚合物贴片组成，其中嵌入了负载顺铂的颗粒 (CP)。 非渗透性背衬可促进药物单向释放、防止药物损失并掩盖顺铂的味道。 顺铂被认为是治疗口腔癌的金标准化疗药物，但其疗效常常受到阻碍。 传统的全身静脉内 (IV) 给药产生显着的全身毒性。 CP 具有优化的尺寸、电荷和渗透参数，以确保顺铂局部保留在肿瘤内 Privo 已对 5 种动物进行了 12 组体内研究。 检验 PRV111 的安全性和有效性 在所有情况下，PRV111 都显示出强大的抗肿瘤作用，并且没有局部或局部的作用。 该提案的目标是成功完成 Privo 的临床试验结果。 Privo 对其专家团队充满信心。 科学家、商业领袖和合作者可以通过里程碑和可交付成果来执行其既定目标。