logo
  

Navidea Announces Positive Initial Results From Phase 2b Trial Of NAV4694

Navidea Biopharmaceuticals Inc.(NAVB) announced Thursday that its investigational beta-amyloid imaging agent, NAV4694, produced highly differentiated images in the first cohort of subjects enrolled in the Company's Phase 2b positron emission tomography or PET imaging study of subjects with Mild Cognitive Impairment or MCI.

The subjects were enrolled and evaluated at the Alzheimer's Disease Center at Quincy Medical Center, Quincy, MA. The results indicate that NAV4694 produced high-quality diagnostic images that segregated MCI subjects into two discrete groups, either amyloid-positive or amyloid-negative.

The image evaluation was performed on twelve subjects meeting pre-defined inclusion/exclusion criteria for emerging, or early-stage, cognitive impairment. NAV4694 scans were assessed by two independent readers using a 3-point visual scale. Image interpretation used the Company's proprietary visual-read algorithm. All twelve MCI subjects segregated into either amyloid-positive or amyloid-negative categories. The technical quality of the scans was good and both raters were in complete agreement on the 3-point scale, with 8 scans highly positive for ß-amyloid and 4 scans negative.

There were no intermediate ratings or ambiguous cases despite the early-stage characterization of the subjects' cognitive impairment status. The scans were easy to read and the readers noted that the high gray matter relative to white matter signal made image interpretation very straight forward. To date, the product candidate appears to be safe and well-tolerated. Results are expected to be presented at an upcoming scientific conference on Alzheimer's disease or AD.

NAV4-04 is a Phase 2b, open-label, multiple-center, non-randomized, PET imaging study to assess the safety and efficacy of NAV4694 in subjects diagnosed with MCI to investigate whether NAV4694 has the ability to detect beta-amyloid in PET scans in subjects with MCI. Enrollment is ongoing and is expected to accelerate in conjunction with the expanded availability of the NAV4694 tracer following the recent completion of technical transfer activities at PET manufacturing facilities.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Consumer Product Safety Commission or CPSC announced recall of thousands of children's Robes made in China and sold exclusively on Amazon.com by various companies. The recalled robes fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children. Further, citing the same concerns, Paper Cape children's pajamas manufactured in Peru ... Health services company Cigna Corp. reported Friday higher profit in its fourth quarter reflecting growth in both Evernorth and Cigna Healthcare segments. Adjusted earnings and topline beat market estimates. Looking ahead for fiscal 2023, the company projects adjusted earnings and adjusted revenues to be higher than last year, but below market view. French drug major Sanofi SA reported Friday higher profit in its fourth quarter with strong revenue growth mainly with strong sales of Dupixent. Looking ahead for fiscal 2023, the company projects higher business earnings, but the expected growth is slower than recorded in fiscal 2022. Sanofi shares were losing around 4 percent in the morning trading in Paris as well as in pre-market activity...
Follow RTT