Breaking News
FONT-SIZE Plus   Neg
Share SHARE

Navidea Reveals Positive Data From Lymphoseek Study; Stock Up - Update

RELATED NEWS
Trade NEOP now with 

Navidea Biopharmaceuticals, Inc (NAVB: Quote), Thursday revealed positive top-line results from an interim analysis of its Phase 3 clinical trial of Lymphoseek Injection in patients with head and neck squamous cell carcinoma.

The interim analysis of its Phase 3 trial, NEO3-06, showed that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes in subjects with squamous cell carcinoma of the head or in the mouth, compared to the removal of all lymph nodes during multiple level nodal dissection surgery of the head and neck.

Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. Lymphoseek was approved by the U.S. Food and Drug Administration in March for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.

The NEO3-06 trial is part of Navidea's strategy to expand Lymphoseek utilization into multiple cancer types and assist in improving the accuracy and extent of cancer diagnosis. The primary endpoint of the trial was based on the number of subjects with pathology-positive lymph nodes (lymph nodes found to harbor cancer) following a multiple level lymph node dissection and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease.

Of the over 80 subjects enrolled in the NEO3-06 trial, 39 subjects were determined to have pathology-positive lymph nodes. Results demonstrated that Lymphoseek accurately identified 38, for an overall False Negative Rate, or FNR of 2.56%, which was statistically significant and met the statistical threshold for success of the primary endpoint.

Navidea expects to close the full dataset and secondary analyzes of the study and evaluate the possibility of filing a Supplemental New Drug Application later this year.

Navidea is trading at $2.70, up 6.08%.

Register
To receive FREE breaking news email alerts for Navidea Biopharmaceuticals, Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Australia's international cricketer Phillip Hughes, who sustained critical injury after being hit on the head by a ball during a domestic match Tuesday, has died. The 25 year-old promising player had been fighting for his life for two days at St Vincent's Hospital in Sydney, in induced coma. Australian cricket team's doctor Peter Brukner said at a news conference Thursday that Hughes died as a After turning in a lackluster performance for much of the session, stocks managed to end Wednesday's trading mostly higher. The gains lifted the Dow and the S&P 500 to new record closing highs, while the Nasdaq reached its best levels since 2000. Half of Americans agree with the changes to immigration policy announced by President Barack Obama last week, according to a CNN/ORC poll, although a majority opposes using executive orders to implement those policies.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.