Navidea Biopharmaceuticals Inc has been awarded a Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA) of the National Institutes of Health (NIH) in connection with the development of the Company’s NAV4694 beta-amyloid imaging agent.
NAV4-04 is a Phase 2b, open-label, multi-center, non-randomized, PET imaging study to assess the safety and efficacy of NAV4694 in subjects diagnosed with MCI to investigate whether NAV4694 PET scan findings have the ability to distinguish subjects with MCI who progress to AD from those who do not. In conjunction with neuro-cognitive testing examinations, subjects are planned to receive three injections of the investigational, diagnostic agent during a 36 month period: at baseline, 18 months and 36 months. The study will determine the specificity of NAV4694 PET imaging to identify the portion of all MCI patients that are at high risk of developing AD dementia and will estimate the rate of progression of the MCI patients with beta-amyloid deposits to AD dementia.
This grant, which follows the recent SBIR award for the Company’s Phase 3 study with NAV4694, will partially support the Phase 2b clinical study which is evaluating NAV4694 as a diagnostic imaging agent that may aid physicians in identifying those individuals with MCI who are at greatest risk of progressing to Alzheimer’s disease (AD).
The SBIR grant has the potential to provide up to $2.3 million in support, if fully funded, through the conclusion of the clinical study. Funding for the approved first stage of the grant ($152,000) is intended to provide support for initiation activities of the clinical trial program. Funding of the second stage of the grant is contingent upon meeting specific aims related to the first stage of the grant such as clinical site contracting, investigator training and institutional review board approvals. Navidea announced the initiation of the Phase 2b trial in March 2013.
