News | June 14, 2013

Navidea Biopharmaceuticals Announces Presentation of Results from Two Lymphoseek and Radiolabeled Colloid Studies in Lymphatic Mapping for Breast Cancer at SNMMI

Single center clinical study and meta-analysis demonstrated ability of Lymphoseek to accurately identify tumor-draining lymph nodes

June 14, 2013 — Biopharmaceuticals Inc. announced results from two separate clinical studies that compared the performance of Lymphoseek (technetium Tc 99m tilmanocept) Injection, a novel receptor-targeted small-molecule radiopharmaceutical recently approved by the U.S. Food and Drug Administration, with that of radiolabeled sulfur colloid in breast cancer patients undergoing diagnostic evaluation in lymphatic mapping procedures. The studies were presented in oral presentations at the 2013 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in Vancouver, Canada.

“Results of our single institution study at UCSD in breast cancer demonstrate the potential that receptor-targeted imaging agents may have in reliably localizing tumor-draining lymph nodes, enhancing efficiencies, and in optimizing patient management post-surgery”

Stephen Povoski, M.D., of The Ohio State University, presented meta-analysis results from Phase 3 clinical trials for Lymphoseek compared with published data for radiolabeled colloid. A single center clinical research study was presented by Jennifer Baker, M.D., University of California San Diego, and detailed that institution’s direct clinical experience with the two agents. Of note, this abstract, "Tilmanocept identifies more positive nodes using fewer sentinel lymph nodes compared to [99mTc] sulfur colloid in early stage breast cancer patients,” received the “Tapan K. Chaudhuri, M.D., FACNM, Award for Best SNM Abstract Involving Breast Cancer Research,” awarded by the Education and Research Foundation for Nuclear Medicine and Molecular Imaging. The award was founded by Chaudhuri with a goal to promote research in breast cancer, and was presented at the SNMMI Annual Meeting to recognize the best paper in breast cancer research.

“We were pleased that these complementary studies of Lymphoseek in lymphatic mapping procedures for patients with breast cancer could be shared at SNMMI, because they highlight performance characteristics of this novel product that are important to clinicians and the patients in their care,” said Mark Pykett, V.M.D., Ph.D., CEO of Navidea Biopharmaceuticals. “Locating appropriate tumor-draining lymph nodes, decreasing patient morbidity by removing as few nodes as possible and scheduling procedures efficiently are key concerns for physicians who conduct lymphatic mapping procedures, and we believe these data further demonstrate the clinical benefit of Lymphoseek in addressing these specific needs.”

“Results of our single institution study at UCSD in breast cancer demonstrate the potential that receptor-targeted imaging agents may have in reliably localizing tumor-draining lymph nodes, enhancing efficiencies, and in optimizing patient management post-surgery,” 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. “Appropriate lymphatic mapping and lymph node biopsy can benefit certain patients by sparing them removal of unnecessary lymphoid tissue and preventing side effects such as lymphedema or swelling, pain and sensory changes, scarring or disfigurement, and extended recovery times.”

Abstract Highlights:

"Tilmanocept identifies more positive nodes using fewer sentinel lymph nodes compared to [99mTc] sulfur colloid in early stage breast cancer patients (Baker et al, University California San Diego)

The independent, retrospective study conducted by UCSD compared the performance of Lymphoseek and radiolabeled sulfur colloid in breast cancer patients at a single institution. Results demonstrated statistically significant results for Lymphoseek in the accurate identification of tumor-draining lymph nodes. Lymphoseek detected 73% of tumor-positive nodes whereas radiolabeled sulfur colloid detected 49%, and Lymphoseek demonstrated a 98% early imaging success rate (the ability of the agent to be imaged in less than 10 minutes). The late imaging failure rate (the ability of the agent to be imaged within two hours) was 0% with Lymphoseek and 11.3% with radiolabeled colloid.

Comparison of key sentinel node biopsy parameters for 99m Tc-tilmanocept (TcTM) and 99mTc-sulfur colloid (TcSC) in breast cancer (Povoski et al, The Ohio State University)

This meta-analysis analyzed the efficacy of Lymphoseek with that of radiolabeled sulfur colloid by using data from Phase 3 clinical trials of Lymphoseek in breast cancer in comparison to published data for radiolabeled sulfur colloid. The study examined the endpoints of localization rate (the percentage of patients with a “hot,” or radioactive, node found), and the degree of localization (the number of “hot” nodes found per patient). The localization rate for Lymphoseek was 99.9% (n=148), which was statistically significant (p<0.001) against that for radiolabeled sulfur colloid with a localization rate of 94%, (n=9,213). Lymphoseek located 2.08 nodes per patient, as compared to 1.6 for radiolabeled sulfur colloid, which was statistically significant (p<0.001)

Full abstracts from SNMMI can be found through the Annual Meeting website at http://interactive.snm.org/index.cfm?pageID=12252.

For more information: www.lymphoseek.com 

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