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
Swiss drug maker Roche Holding said a late-stage trial of its breast cancer drug Kadcyla did not provide superior results compared with an existing therapy. FCA US, until recently known as Chrysler, said Friday it is recalling 257,000 Dodge Ram pickups. The auto maker says the rear axle pinion nut on certain model year 2005 Dodge Ram 1500 trucks may loosen due to an undersized spline on the pinion gear. If the pinion nut loosens, the rear axle may... This medical device company has a very impressive track record of growing business over the past decade. increasing sales from $490.2 million in 2004 to $1.72 billion this year. The Silicone Hydrogel daily disposable lens portfolio constitutes a major avenue for growth.
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.