Navidea Biopharmaceuticals (NYSE:NAVB) is getting some financial support from the NIH for its Alzheimer’s diagnostic technology as it advances into Phase 3 development.
The National Institute of Aging awarded up to $1.8 million for a late-stage clinical trial of the Navidea’s PET beta-amyloid imaging agent, the company said. NAV4694 is designed to help clinicians detect Alzheimer’s in patients by binding to beta-amyloid deposits in the brain, making them appear in PET scans.
Columbus, Ohio-based Navidea also inked a manufacturing deal with Siemens PETNET Solutions to manufacture and supply other services for late-stage development of NAV4694. It’s also currently being evaluated in two Phase 2 efficacy studies.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The presence of amyloid plaques in the brain has been considered a hallmark of neurodegenerative disease for years now. So the thought is that being able to see that those plaques are building up would give clinicians a better way to diagnose the disease even before cognitive symptoms set in. The importance of early diagnosis is downplayed, though, by the fact that scientists have not yet figured out how to stop Alzheimer’s. So far, none of the disease-modifying drugs developed based on the amyloid hypothesis have passed late-stage clinical trials.
Meanwhile, as Navidea, GE Healthcare and others advance PET amyloid beta imaging agents, the Centers for Medicare & Medicaid Services is raising concerns by suggesting that it won’t provide broad reimbursement for them. In response Amyvid, a similar agent developed by Avid Radiopharmaceuticals and approved by the FDA in 2012, CMS released a proposed decision memo under which it would cover PET amyloid-beta imaging tests only in very specific circumstances. CMS attributed that to “insufficient evidence” that the agent improves outcomes for people with neurodegenerative disease.
Navidea, formerly Neoprobe, has three other radiopharmaceutical programs under development: RIGScan and Lymphoseek (FDA approved in March) for cancer detection and mapping, and NAV5001 for neuroimaging for Parkinson’s disease and dementia.
