Navidea Biopharmaceuticals, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, has been awarded a Small Business Innovation Research (SBIR) grant from the National Institute On Aging (NIA) of the NIH in connection with the company's phase III clinical program for its NAV4694 beta-amyloid imaging agent as an aid in the differential diagnosis of Alzheimer's disease.
The SBIR grant has the potential to provide up to $1.8 million in support, if fully funded, through the conclusion of the phase III clinical study. Funding for the approved first stage of the grant ($259,000) is intended to provide support for initiation activities of the phase III clinical 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 institutional review board approval of the phase III protocol, clinical site contracting and investigator training. Navidea announced the initiation of the phase III program in June.
"We expect this trial will further highlight several of the features of NAV4694 such as high amyloid binding/sensitivity, low white matter uptake, strong signal-to-noise ratios and clear, unambiguous images," said Frederick Cope, Ph.D., FACN, Navidea senior vice president and chief scientific officer. "We believe that earlier and more effective diagnosis is directly in line with the federal government's aim to address the impact of this devastating disease."
"The phase III study is designed to provide a direct comparison of NAV4694 patient images collected during life with postmortem histopathology findings. The results from this study may lead to improved differential diagnosis and patient management," said Cornelia Reininger, M.D., Ph.D., Navidea senior vice president and chief medical officer.