Tag Archives: Lymphoseek Phase

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Navidea Biopharmaceuticals Announces Positive Top-Line Results from Interim Analysis of Lymphoseek®

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Navidea Biopharmaceuticals Announces Positive Top-Line Results from Interim Analysis of Lymphoseek ® Phase 3 Clinical Trial in Head and Neck Cancer


– Lymphoseek Meets Primary Endpoint in Identification of Sentinel Lymph Nodes Against Pathology Gold Standard –

DUBLIN, Ohio–(BUSINESS WIRE)– Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), 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 …read more

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Results of Lymphoseek® Phase 3 Clinical Trials in Breast Cancer Published in Annals of Surgical Onco

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Results of Lymphoseek ® Phase 3 Clinical Trials in Breast Cancer Published in Annals of Surgical Oncology


– Lymphoseek Meets Primary Efficacy Endpoint in Assessment of Lymphatic Mapping Performance in Patients with Breast Cancer –

DUBLIN, Ohio–(BUSINESS WIRE)– Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, today announced the peer-reviewed publication of results from two Phase 3 clinical trials of Lymphoseek® (technetium 99m tilmanocept) Injection in patients with breast cancer. The trials assessed the performance of Lymphoseek against the standard of care, vital blue dye (VBD), in lymphatic mapping. Results demonstrated that Lymphoseek met its primary efficacy endpoint of rate of agreement, or concordance, with VBD. The study, “Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials,” was published in the current online edition of the journal Annals of Surgical Oncology [DOI 10.1245/s10434-013-2887-8].

Lymphoseek is a receptor-targeted radiopharmaceutical recently approved by the U.S. Food and Drug Administration and indicated for use in lymphatic mapping for breast cancer and melanoma. In this procedure key lymph nodes adjacent to a primary tumor, that may contain tumor metastases, are identified and biopsied to determine if cancer has spread to these lymph nodes.

“Lymphoseek was specifically designed to provide clinicians who perform lymphatic mapping procedures with actionable information, and we believe that the data reported in this publication demonstrate its utility and safety in identifying tumor-draining lymph nodes,” said Frederick Cope, Ph.D., Senior Vice President, Pharmaceutical Research and Clinical Development of Navidea. “These data from breast cancer patients, in conjunction with previously published data from our Phase 3 clinical trials in melanoma, comprise part of our NDA registration package for Lymphoseek with the FDA. We are confident that Lymphoseek may hold significant improvement for patients who undergo lymphatic mapping procedures.”

“Tilmanocept was originally developed at UCSD as a targeted molecular approach to help stage breast cancer and melanoma patients, and we advanced the agent through Phase 1 clinical trials with funding provided by Susan G. Komen Breast Cancer Foundation and the American Cancer Society,” said Anne Wallace, M.D., Chief, Division of Plastic Surgery; Professor of Surgery, UC San Diego School of Medicine; Director of the Breast Care Unit; UC San Diego Moores Cancer Center; and a Principal Investigator in the Lymphoseek Phase 3 clinical trials. “The results from these Phase 3 clinical trials …read more
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FDA Approves Navidea's Lymphoseek® (technetium Tc 99m tilmanocept) Injection for Use in Lymphatic Ma

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FDA Approves Navidea’s Lymphoseek ® (technetium Tc 99m tilmanocept) Injection for Use in Lymphatic Mapping

The first receptor-targeted radiopharmaceutical approved for lymphatic mapping in breast cancer and melanoma patients


Company to Host Conference Call at 4:00 p.m., March 13, 2013

DUBLIN, Ohio–(BUSINESS WIRE)– Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval of Lymphoseek® (technetium Tc 99m tilmanocept) Injection, a novel product indicated for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek is a receptor targeted radiopharmaceutical designed to identify these lymph nodes which have the highest probability of harboring cancer and thereby assist physicians in the staging of such patients.

Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor. Accurate staging of lymph nodes is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 232,000 new cases of breast cancer and 77,000 new cases of melanoma are expected to be diagnosed in the United States in 2013.1

“We recommend lymphatic node mapping and sentinel node biopsy for patients with early stage breast cancer and in select cases of ductal carcinoma in situ,” said Anne Wallace, M.D., Professor of Surgery, UC San Diego School of Medicine; Director of the Breast Care Unit; UC San Diego Moores Cancer Center; and Principal Investigator for breast cancer in the Lymphoseek Phase 3 clinical trials. “The ability to reliably identify multi-node pathology-positive patients is important to optimize their post-surgery management and to spare certain patients from unnecessary surgery and potentially debilitating side effects. Products specifically designed to address reliable lymph node uptake and retention can provide significant clinical utility and help standardize the process of lymph node mapping.”

“Both the incidence rate and the death rate for melanoma continue to increase, in the United States and in many other parts of the world,” said Vernon K. Sondak, M.D., Chair, Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa Fla., and Principal Investigator for melanoma in the Lymphoseek Phase 3 clinical trials. “Most patients present …read more
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