Navidea keys up Alzheimer's Dx agent for Phase III

Navidea ($NAVB) is racing to get its beta-amyloid-detecting imaging agent on the market, kicking off enrollment in a Phase III trial for the Alzheimer's-related diagnostic.

The company is recruiting 275 near-death patients, looking to compare how well its NAV4694 imaging agent can detect beta-amyloid deposits in the brain, biomarkers tied to Alzheimer's development. After the subjects have died, Navidea will check for deposits through autopsy, examining the agent's sensitivity and specificity.

As it stands, autopsy is the only sure-fire way to diagnose Alzheimer's, Navidea said, and the company's agent, used to light up beta-amyloids in PET scans, could allow for earlier detection and therapeutic intervention, Chief Medical Officer Connie Reininger said.

"Results from earlier trials using NAV4694 support our conviction that the outstanding performance characteristics of this imaging biomarker--which include favorable sensitivity, specificity, rapid brain uptake and improved image clarity due to low white-matter uptake--position NAV4694 as a true 'best-in-class' second generation agent to aid in the diagnosis of Alzheimer's disease and with the potential to enable diagnosis earlier in the course of disease," Reininger said in a statement.

While Navidea is so far pleased with its agent's progress, the company lags behind GE Healthcare ($GE), which posted positive Phase III results last far for its beta-amyloid-tracking product. In a study of 180 end-of-life patients, GE's flutemetamol ferreted out brain deposits with a median sensitivity ranging from 75% to 100% and specificity ranging from 99% to 100%. Since then, GE has licensed its investigative agent to Merck ($MRK) and Eisai, allowing the drugmakers to screen potential trial participants as they develop amyloid inhibitor Alzheimer's treatments.

- read Navidea's announcement