Customized Nanotechnology Based Treatment of Oral Cancer

基于纳米技术的口腔癌定制治疗

• 批准号: 9048578
• 负责人: Manijeh N Goldberg
• 金额: $ 100万
• 依托单位: PRIVO TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2018-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9048578
• 关键词: Aftercare; American; Animals; Award; Biological Assay; Bolus Infusion; Businesses; Cessation of life; Chemicals; Chemistry; Cisplatin; Clinical; Clinical Trials; Contracts; Development; Development Plans; Diagnosis; Disease; Documentation; Dose; Drug Delivery Systems; Drug Exposure; Elements; Ensure; Evaluation; Exposure to; Foundations; Funding; Goals; Gold; Grant; Guidelines; Hamsters; High Pressure Liquid Chromatography; Hour; Hygiene; In Vitro; Incidence; Intravenous; Investigation; Investigational Drugs; Life; Malignant neoplasm of pharynx; Methodology; Methods; Mus; Nanotechnology; National Cancer Institute; National Institute of Dental and Craniofacial Research; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Plant Roots; Platinum; Procedures; Process; Production; Property; Quality Control; Recurrence; Research; Research Contracts; Research Design; Resources; Rest; Risk; Safety; Scientist; Seasons; Small Business Innovation Research Grant; Solubility; Specific qualifier value; Sterilization; Survival Rate; Technology; Testing; Topical application; Toxic effect; United States Food and Drug Administration; Work; base; cancer therapy; chemotherapy; commercialization; cost effective; design; improved; in vivo; intravenous administration; local drug delivery; malignant mouth neoplasm; manufacturing process; manufacturing scale-up; meetings; mortality; nanoengineering; nanoparticle; novel therapeutics; preclinical study; programs; public health relevance; research and development; research study; safety study; scale up; sterility testing; systemic toxicity; tumor

 DESCRIPTION (provided by applicant): In this proposal, Privo describes its research and development plans in order to obtain Food and Drug Administration (FDA) Investigational New Drug (IND) status for its localized nanoparticle based chemotherapy wafer for safely treating oral cancer. According to the Oral Cancer Foundation, over 43,250 Americans will be diagnosed with oral and pharyngeal cancer this year, causing over 8,000 deaths, roughly one person every hour. In 2011, over 640,000 new oral cancer cases were diagnosed worldwide, and only half will live more than 5 years after initial diagnosis. By 2020, the annual worldwide incidence is predicted to increase to over 840,000, a 30% rise, and the annual mortality to increase to nearly 480,000, approximately a 37% increase. Currently, cisplatin is at the forefront of platinum based chemotherapeutics for treating oral cancer. However, its successful administration is frequently hindered by its significant systemic toxicity as a result of traditional bolus systemic intravenous (IV) administration. Privo Technologies is a company with roots in MIT's Langer Lab which has developed a nanoengineered ChemoThin Wafer (CTW(c)) for topical and local delivery of chemotherapy agent cisplatin (CIS) to oral cancer tumors. This technology has been awarded more than $3 million in non- dilutive funding, including a recent approval of $2.3 million funding from the National Cancer Institute (NCI) for its IND enabling preclinical studies. Privo's treatmen has been shown to be safer and more effective than the gold standard intravenous (IV) cisplatin. CTW(c) is easy to administer, and takes only 1 hour to complete the application. It has caused complete tumor regression in animals after 6 treatments. In this proposal, Privo requests funding from NIDCR which, when combined with the NCI funding, will provide Privo the adequate resources to obtain its FDA Investigational New Drug (IND) status. This proposal includes performing the Chemistry Manufacturing and Control (CMC) process required prior to clinical trials, developing required assays including the identity assay, potency assay of the active pharmaceutical ingredient (cisplatin), and purity assay, the establishment of GMP manufacturing, and sourcing pharmaceutical grade raw materials. Privo believes that its CTW(c) aligns closely with the aims of NIDCR in providing a safer, more effective, and less costly treatment for oral cancer.

 描述（由申请人提供）：在本提案中，Privo 描述了其研究和开发计划，以获得美国食品和药物管理局 (FDA) 的研究性新药 (IND) 状态，用于安全治疗口腔癌的基于局部纳米颗粒的化疗晶片。据口腔癌基金会称，今年将有超过 43,250 名美国人被诊断出患有口腔癌和咽癌，导致超过 8,000 人死亡，大约每小时就有一人死亡。 2011年，全球新诊断出超过64万例口腔癌病例，只有一半病例在初次诊断后能活过5年以上。到 2020 年，全球每年发病率预计将增加到 84 万以上，增加 30%，年死亡率将增加到近 48 万，增加约 37%。目前，顺铂处于治疗口腔癌的铂类化疗药物的最前沿。然而，由于传统的推注全身静脉注射，其显着的全身毒性常常阻碍其成功给药。 （四）行政管理。 Privo Technologies 是一家源自麻省理工学院 Langer 实验室的公司，该公司开发了一种纳米工程 ChemoThin Wafer (CTW(c))，用于将化疗药物顺铂 (CIS) 局部递送至口腔癌肿瘤。该技术已获得超过 300 万美元的非稀释性资金，其中包括美国国家癌症研究所 (NCI) 最近批准的 230 万美元资金，用于其 IND 临床前研究。 Privo 的治疗方法已被证明比金标准静脉注射 (IV) 顺铂更安全、更有效。 CTW(c) 易于管理，只需 1 小时即可完成申请。经过 6 次治疗后，它已使动物肿瘤完全消退。在此提案中，Privo 请求 NIDCR 提供资金，该资金与 NCI 资金相结合，将为 Privo 提供足够的资源，以获得 FDA 的研究性新药 (IND) 状态。该提案包括执行临床试验前所需的化学制造和控制 (CMC) 流程、开发所需的检测方法，包括活性药物成分（顺铂）的身份检测、效力检测和纯度检测、建立 GMP 生产以及采购药品级原材料。 Privo 认为，其 CTW(c) 与 NIDCR 的目标密切一致，即为口腔癌提供更安全、更有效且成本更低的治疗方法。