Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the award of 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. 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.
“There is a great clinical need to develop better methods to identify individuals who are at high risk of developing dementia caused by AD before their symptoms become severe. Beta-amyloid plaque, which is indicative of AD, begins to appear in the brains of AD patients many years before they develop dementia,” said Cornelia Reininger, MD, PhD, Navidea Senior Vice President and Chief Medical Officer. “The outcome of this trial may enable earlier and accurate differentiation of MCI subjects who are at risk of developing AD from those who are not, before the disease has advanced to the stage of impairing daily activities. If diagnosed at an earlier stage, the avenues for disorder management and therapeutic intervention could be improved considerably.”
"We very much appreciate the additional support of the NIH as we conduct this valuable clinical trial aimed at evaluating a patient population in whom dementia is just emerging," said Frederick Cope, PhD, FACN, Navidea Senior Vice President and Chief Scientific Officer. “Earlier and more effective diagnosis of cognitive impairment and dementia is clearly a priority of the federal government’s initiative to address important medical unmet needs in these areas. We believe the strong biochemical performance elements embodied in NAV4694 such as high amyloid binding and low white matter uptake for clearer images may differentiate NAV4694 in the effort to assist in earlier differential diagnoses in patients with disorders such as MCI.”