EXERCISE PHASE II TITLE: DEVELOPMENT OF BIO 300 AS A RADIATION MODULATOR FOR USE DURING RADIOTHERAPY OF LUNG CANCER ; PERIOD OF PERFORMANCE FROM 09/20/2012 TO 01/09/2016DUNS: 197085517CAN8478361

练习第二阶段标题：开发 BIO 300 作为肺癌放射治疗期间使用的辐射调节剂；

• 批准号: 8948720
• 负责人: MICHAEL KAYTOR
• 金额: $ 149.92万
• 依托单位: HUMANETICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-20 至 2016-01-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8948720
• 关键词: A549; Antioxidants; Cancer Cell Growth; Cancer Etiology; Cancer Model; Cessation of life; Clinical Research; Clinical Trials; Data; Development; Drug Kinetics; Exercise; Genistein; Growth; Human; Injectable; Investigational Drugs; Lung Neoplasms; Malignant Neoplasms; Malignant neoplasm of lung; Morbidity - disease rate; Mus; Non-Small-Cell Lung Carcinoma; Normal tissue morphology; Oral; Patients; Performance; Pharmaceutical Preparations; Phase; Radiation; Radiation therapy; Radioprotection; Research; Safety; Series; Suspension substance; Suspensions; Temperature; Testing; Toxic effect; United States; Xenograft procedure; aqueous; improved; mortality; neoplastic cell; research study; response; tissue culture; tumor growth

Lung cancer is the most common cause of cancer-related deaths in the United States. Humanetics will develop BIO 300 as a drug that can be given with radiotherapy for lung cancer to help improve efficacy and to decrease toxicity. The focus of the development will be with non-small cell lung cancers where BIO 300 has already shown an ability to inhibit cancer growth. BIO 300 also has a demonstrated ability to protect normal tissues exposed to radiation. In Phase I of this proposal, we will complete a series of mouse efficacy studies assessing BIO 300’s ability to inhibit tumor growth in an A549 xenograft non-small cell lung cancer model as well as evaluating the effects on normal tissues. In Phase II we will use the research results of the Phase I experiments along with the existing BIO 300 safety data to file an IND for the use of BIO 300 in patients receiving radiotherapy for non-small cell tumors of the lung. Once FDA clearance is obtained we will proceed with a clinical study to assess the safety and effect of BIO 300 in improving the morbidity and mortality in patients receiving radiation therapy for non-small cell lung cancer.

肺癌是美国癌症相关死亡的最常见原因。Humanetics公司将把bio300开发为可以与肺癌放射治疗一起使用的药物，以提高疗效和降低毒性。开发的重点将是非小细胞肺癌，BIO 300已经显示出抑制癌症生长的能力。BIO 300还具有保护暴露在辐射下的正常组织的能力。