This Day On The Street
Continue to site
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

Navidea Biopharmaceuticals Reaches Interim Analysis Point Of Phase 3 Head And Neck Cancer Study Of Lymphoseek®

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals today announced that it has accrued sufficient subjects in its NEO3-06 study in patients with head and neck cancer to enable the Company to conduct a pre-planned interim analysis. This Phase 3 trial of Lymphoseek® (technetium Tc 99m tilmanocept) Injection, a novel intraoperative lymphatic mapping (ILM) agent, is designed to demonstrate the performance of Lymphoseek in identifying sentinel lymph nodes in subjects with squamous cell carcinoma on the head or in the mouth. The interim analysis will compare the pathological analysis of the sentinel lymph nodes localized using Lymphoseek with that of all the lymph nodes removed during a full nodal dissection surgery of the head and neck. This full dissection surgery is considered the gold standard for determining the presence and extent of cancer and staging of the disease in such patients. A total of 82 subjects who underwent pre-planned, full dissection surgery were enrolled and represent the interim analysis cohort. Results from the interim statistical analysis and reporting of the findings will be available upon completion of full site and data audits planned for later in 2013.

“We believe this study is unique because it compares Lymphoseek’s performance to a pathological ‘ truth standard’ obtained from a head and neck cancer procedure in which the entire regional lymph node population is removed,” commented Fred Cope, Ph.D., Navidea’s Senior Vice President of Pharmaceutical Research and Drug Development. “In 2012, positive data from three sites participating in this study were presented at medical meetings by independent investigators characterizing the performance of Lymphoseek at their individual study centers in identifying sentinel lymph nodes in head and neck squamous cell carcinoma. The results appeared very promising. These investigators reported that, for patients accrued up to that date, Lymphoseek had a 0% false negative rate and was 100% predictive of the pathological status of the patient.”

Dr. Cope added, “In head and neck cancer it is not uncommon to remove 40, 50, or even 100 regional lymph nodes during full dissection surgery, which can result in substantial and long-term morbidity for patients. An effective sentinel lymph node mapping agent could markedly limit the number of lymph nodes required to conduct pathological assessment and determine whether the cancer has spread. We believe that the NEO03-06 study may provide additional data to demonstrate Lymphoseek’s usefulness in characterizing this important type of cancer, and potentially support its use as a sentinel lymph node mapping agent that can facilitate accurate cancer staging and decrease the extent of surgery for some patients, thereby reducing possible serious morbidity.”

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $95.03 -2.90%
FB $116.73 7.20%
GOOG $691.20 -2.10%
TSLA $247.54 -1.60%
YHOO $36.58 -1.00%


Chart of I:DJI
DOW 17,830.76 -210.79 -1.17%
S&P 500 2,075.81 -19.34 -0.92%
NASDAQ 4,805.2910 -57.85 -1.19%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs