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

肺癌是美国最常见的癌症相关死亡原因。人文科学公司将开发BIO 300作为一种药物，可以在肺癌放射治疗的同时给予，以帮助提高疗效并减少毒性。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还被证明有能力保护暴露在辐射中的正常组织。 在该方案的第一阶段，我们将完成一系列小鼠疗效研究，评估BIO 300‘S在A549异种移植非小细胞肺癌模型中抑制肿瘤生长的能力，以及对正常组织的影响。 在第二阶段，我们将使用第一阶段实验的研究结果以及现有的BIO 300安全数据来提交一份IND，用于接受肺部非小细胞肿瘤放射治疗的患者使用BIO 300。一旦FDA批准，我们将继续进行一项临床研究，以评估BIO 300在改善接受放射治疗的非小细胞肺癌患者的发病率和死亡率方面的安全性和有效性。

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.