This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Navidea Biopharmaceuticals Announces Enrollment Of First Subject In Phase 2 Trial Of NAV4694 As An Aid In Diagnosing Alzheimer’s Disease

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that enrollment has commenced at two sites participating in its Phase 2, open-label, safety and efficacy PET imaging study of [ 18F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with probable Alzheimer’s disease (AD). The study is designed to compare images from subjects with probable AD with similarly aged and young healthy volunteers (HV). Two trial sites are currently enrolling subjects: Molecular NeuroImaging, LLC in New Haven, CT, which dosed the first patient in the study; and the Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA.

“We are pleased to participate in this clinical study of NAV4694 which has the potential to help advance diagnostic accuracy in people with Alzheimer’s disease,” said Danna Jennings, M.D., Clinical Research Director, Molecular NeuroImaging, LLC. “NAV4694 appears to exhibit the strengths of 11C PIB but given that the ligand is labeled with 18 F it offers flexibility and is more practical to use. The data at this point in the development suggest that NAV4694 shows favorable sensitivity, specificity and decreased white-matter uptake that may enable earlier Alzheimer’s disease identification, better monitoring of disease progression, and easier scan interpretation.”

“In addition to safety and efficacy endpoints, this clinical trial will allow us to evaluate NAV4694 to determine the correlation of the clinical diagnosis with the β-amyloid plaque uptake in PET images of subjects diagnosed with probable AD,” commented Frederick Cope, Ph.D., F.A.C.N., C.N.S., Navidea’s Senior Vice President, Pharmaceutical Research and Clinical Development. “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."

This is a phase 2, open-label, multiple-center, non-randomized single dose, PET imaging study to assess the safety and efficacy of [18F]NAV4694 in detecting β-amyloid plaque in the brain in subjects with probable Alzheimer’s disease compared with similarly aged and young healthy volunteers. In addition to safety and efficacy objectives, this study also will measure the correlation between neuro-psychiatric test results with the amount of β-amyloid determined by the NAV4694 imaging.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,279.74 +13.75 0.08%
S&P 500 2,010.40 -0.96 -0.05%
NASDAQ 4,579.7890 -13.6380 -0.30%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs