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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research – Phase I (N43)
Project #
261201200078C-0-0-1
Application #
8566154
Study Section
Project Start
2012-09-20
Project End
2013-06-19
Budget Start
Budget End
Support Year
Fiscal Year
2012
Total Cost
$197,224
Indirect Cost
Name
Humanetics Corporation
Department
Type
DUNS #
197085517
City
Minneapolis
State
MN
Country
United States
Zip Code
55416