SBIR-STTR Award

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[unreadable]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.

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.

Project Terms:
A549; Antioxidants; aqueous; Cancer Cell Growth; Cancer Etiology; Cancer Model; Cessation of life; Clinical Research; Clinical Trials; Data; Development; Drug Kinetics; Exercise; Genistein; Growth; Human; improved; Injectable; Investigational Drugs; Lung Neoplasms; Malignant neoplasm of lung; Malignant Neoplasms; Morbidity - disease rate; Mortality Vital Statistics; Mus; neoplastic cell; Non-Small-Cell Lung Carcinoma; Normal tissue morphology; Oral; Patients; Performance; Pharmaceutical Preparations; Phase; Radiation; Radiation therapy; Radioprotection; Research; research study; response; Safety; Series; Suspension substance; Suspensions; Temperature; Testing; tissue culture; Toxic effect; tumor growth; United States; Xenograft procedur