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

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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.