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Navidea Biopharmaceuticals, Inc.
, a biopharmaceutical company
focused on the development and commercialization of precision diagnostic
radiopharmaceuticals, today announced top-line results from the interim
analysis of its Phase 3 clinical trial, NEO3-06, of Lymphoseek^® (technetium
99m tilmanocept) Injection in patients with head and neck squamous cell
carcinoma. Results of the pre-planned interim analysis demonstrated that
Lymphoseek met the primary efficacy endpoint of accurately identifying
sentinel lymph nodes (SLNs) in subjects with squamous cell carcinoma of the
head or in the mouth, as compared to the removal of all lymph nodes during
multiple level nodal dissection surgery of the head and neck. Multiple level
nodal dissection surgery is considered the “gold standard” to determine the
presence and extent of cancer spread in lymph nodes of patients with head and
neck squamous cell carcinoma. Lymphoseek was approved by the U.S. Food and
Drug Administration in March, 2013 for use in lymphatic mapping to assist in
the localization of lymph nodes draining a primary tumor in patients with
breast cancer or melanoma.
“These interim results are highly encouraging for this patient population who
generally face extensive surgery to properly stage their cancer,” said
Mark J. Pykett, V.M.D, Ph.D., President and CEO of Navidea. “This study is
part of Navidea's strategy to expand Lymphoseek utilization into multiple
cancer types and assist physicians in improving the accuracy and extent of
cancer diagnosis for their patients. In light of the positive top-line
results, and with consideration for the effect of these surgeries on patients,
the study's Data Safety Monitoring Committee (DSMC) has recommended that we
close the NEO3-06 trial early, a possibility the Company will assess as the
full dataset becomes available. We expect to complete the full dataset and
secondary analyses of this study, present them at major scientific meetings in
the coming months, and evaluate the possibility of filing a Supplemental New
Drug Application (sNDA) later this year.”
The primary endpoint for the NEO3-06 trial was based on the number of subjects
with pathology-positive lymph nodes (that is, 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 of these 39 patients, Lymphoseek accurately identified 38, for an overall
False Negative Rate (FNR) of 2.56%, which was statistically significant
(p=0.0205) and met the statistical threshold for success of the primary
endpoint. These findings indicate that Lymphoseek accurately identified SLNs
in these trial subjects, and is likely to be predictive of overall node
pathology status. FNR is the rate of occurrence of negative test results in
subjects known to have the disease for which the individual is being tested.
Moreover, multiple level nodal dissection of patients in the trial with
cancer-positive lymph nodes led to an average removal of 38 lymph nodes per
patient, whereas Lymphoseek on average led to the removal of approximately 4
lymph nodes, representing a substantial reduction in potential morbidity for
patients with head and neck cancer undergoing sentinel lymph node biopsy.
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