Navidea Biopharma Reports Top-Line Results from Interim Analysis of Lymphoseek Phase 3 Trial

Navidea Biopharmaceuticals, Inc. (NYSE: NAVB), a biopharmaceutical companyfocused on the development and commercialization of precision diagnosticradiopharmaceuticals, today announced top-line results from the interimanalysis of its Phase 3 clinical trial, NEO3-06, of Lymphoseek^® (technetium99m tilmanocept) Injection in patients with head and neck squamous cellcarcinoma. Results of the pre-planned interim analysis demonstrated thatLymphoseek met the primary efficacy endpoint of accurately identifyingsentinel lymph nodes (SLNs) in subjects with squamous cell carcinoma of thehead or in the mouth, as compared to the removal of all lymph nodes duringmultiple level nodal dissection surgery of the head and neck. Multiple levelnodal dissection surgery is considered the “gold standard” to determine thepresence and extent of cancer spread in lymph nodes of patients with head andneck squamous cell carcinoma. Lymphoseek was approved by the U.S. Food andDrug Administration in March, 2013 for use in lymphatic mapping to assist inthe localization of lymph nodes draining a primary tumor in patients withbreast cancer or melanoma.“These interim results are highly encouraging for this patient population whogenerally face extensive surgery to properly stage their cancer,” saidMark J. Pykett, V.M.D, Ph.D., President and CEO of Navidea. “This study ispart of Navidea's strategy to expand Lymphoseek utilization into multiplecancer types and assist physicians in improving the accuracy and extent ofcancer diagnosis for their patients. In light of the positive top-lineresults, and with consideration for the effect of these surgeries on patients,the study's Data Safety Monitoring Committee (DSMC) has recommended that weclose the NEO3-06 trial early, a possibility the Company will assess as thefull dataset becomes available. We expect to complete the full dataset andsecondary analyses of this study, present them at major scientific meetings inthe coming months, and evaluate the possibility of filing a Supplemental NewDrug Application (sNDA) later this year.”The primary endpoint for the NEO3-06 trial was based on the number of subjectswith pathology-positive lymph nodes (that is, lymph nodes found to harborcancer) following a multiple level lymph node dissection and required aminimum of 38 subjects whose lymph nodes contained pathology-confirmeddisease. Of the over 80 subjects enrolled in the NEO3-06 trial, 39 subjectswere determined to have pathology-positive lymph nodes. Results demonstratedthat of these 39 patients, Lymphoseek accurately identified 38, for an overallFalse Negative Rate (FNR) of 2.56%, which was statistically significant(p=0.0205) and met the statistical threshold for success of the primaryendpoint. These findings indicate that Lymphoseek accurately identified SLNsin these trial subjects, and is likely to be predictive of overall nodepathology status. FNR is the rate of occurrence of negative test results insubjects known to have the disease for which the individual is being tested.Moreover, multiple level nodal dissection of patients in the trial withcancer-positive lymph nodes led to an average removal of 38 lymph nodes perpatient, whereas Lymphoseek on average led to the removal of approximately 4lymph nodes, representing a substantial reduction in potential morbidity forpatients with head and neck cancer undergoing sentinel lymph node biopsy.