Research Project
7278323
[unreadable] DESCRIPTION (provided by applicant): The LIGO-069-136 Phase II renewal project is a critical path research and development plan designed to qualify an anti-inflammatory monoclonal antibody product for approval of an investigative new drug (INO) for chronic bronchitis. The proposed mechanism of action of LlGO-069-136 is the prevention of neutrophil and monocyte adherence to endothelial cells, and subsequent extravasation to the inflamed lung tissue, via blockade of E- and L-selectin, an adhesion molecule responsible for the trafficking of leukocytes from the blood into tissues. It is proposed that this blockade will break the cycle of inflammation responsible for the progressive lung damage that characterizes acute exacerbations of chronic bronchitis (AECB), chronic bronchitis (CB) and COPD. Described in the plan is the detailed preclinical research and development program including efficacy testing, manufacturing, pharmacology, toxicology and INO preparation. LigoCyte expects to fund major portions of the preclinical activity, including the initial efficacy testing of LIGO-069-136 in a non-human primate LPS lung inflammation model and development and manufacturing of the drug substance and drug product. Under the Phase II SBIR renewal funding, LigoCyte will conduct the extensive candidate product testing required for safety (toxicity) and a determination of its biological properties (pharmacology). In addition to assay development work and product testing being done at LigoCyte, much of this work will be done in collaboration with contract research organizations (CROs) that have the capability to conduct manufacturing and/or research under GMP/GLP conditions and regulations. Ultimately, the goal of the program is to provide the FDA with the necessary data to approve LlGO-069-136 for human clinical trials. The subsequent human clinical testing will establish the safety and efficacy of the product as a therapy for managing infection-inflammation driven exacerbations of chronic bronchitis and COPD and establish its ability to slow or arrest disease progression. [unreadable] [unreadable] [unreadable]
