Grant: Proof of Principle Program - Phase I

Lung cancer is the most common cause of cancer deaths worldwide with more than 1.2 million people dying of the disease annually. In Canada, there are more that 23,000 new cases a year. The overall 5-year survival is only 16%. A promising strategy to reduce lung cancer mortality and morbidity is to detect lung cancer early and offer post-operative chemotherapy only to those with microscopic residual disease to avoid futile treatment and unnecessary toxicity Our research is based on discovery of a novel protein in the blood called Connective Tissue-Activating Peptide III(CTAP III)(J of Clin Oncol 2009 Jun 10;27(17):2787-92. PCT patent application filed Nov. 24, 2008). CTAP III was found to be able to detect early lung cancer up to 30 months before clinical diagnosis. It decreased in patients who are cured by surgery but remained elevated in those who later developed recurrent cancer. The current commercially-available (for research use only) antibody kits for CTAP III are suboptimal as it detects broken down forms of CTAP III such as NAP-2. We have produced a panel of monoclonal antibodies (mAbs) that are more specific against CTAP III. This research aims at selecting the most sensitive and specific antibodies; develop our own ELISA blood test kit, compare the performance of our ELISA test with the commercial test kit to determine if we can improve the sensitivity and specificity to detect early lung cancer and microscopic residual cancer after surgery. Successful development of this diagnostic test will have significant clinical applications. It is expected that additional patent applications will be filed to protect the composition and use of these novel new mAbs in lung cancer detection. This proposal fits within the Proof of Principle program as it will set the stage for technology transfer of the test to a commercialization partner in support of prospective clinical trials, regulatory submissions and subsequent implementation as a clinical diagnostic test