Moving on from the FDA's rejection of its cancer diagnostic tool, Navidea ($NAVB) is launching a Phase II trial for its next-generation Alzheimer's imaging agent.
The Dublin, OH, company has recruited its first subject in a new trial of NAV4694, designed to detect beta amyloid deposits in the brain and a biomarker for future Alzheimer's development. The study is designed to test the safety and efficacy of the agent in finding beta amyloid deposits in subjects with probable Alzheimer's disease, compared with healthy volunteers.
"Our ultimate goal is to provide an improved diagnostic tool with outstanding performance characteristics for physicians to aid in the diagnosis of AD, a disease expected to impact as many as 16 million Americans by 2050," Navidea Senior Vice President of Pharmaceutical Research and Clinical Development Frederick Cope said in a statement.
Navidea trails GE Healthcare ($GE) in the race to get a beta amyloid-detecting agent on the market. GE recently presented the results of a Phase III study of its agent, flutemetamol, and the company expects to file for regulatory approvals in the U.S. and European Union later this year.
Navidea is coping with the FDA's rejection of Lymphoseek, a cancer diagnostic tool designed to bind to the lymph nodes and find those that drain from a primary tumor in patients with breast cancer or melanoma. Earlier this month, the agency took issue the third-party contract manufacturer Navidea employed to produce Lymphoseek, not the agent's safety and efficacy data, the company said. Still, the FDA's ruling further delays Navidea from cashing in on Lymphoseek, which analysts have said could bring in revenue of $36.5 million next year and grow to $150 million annually by 2016.
- read Navidea's release