News | June 09, 2015

Navidea Reports Positive Lymphoseek Comparative Results in Breast Cancer Injection Site Pain Study

Patients experienced statistically significantly less pain prior to sentinel lymph node biopsy with Lymphoseek than with Tc-99m Sulfur Colloid

June 9, 2015 - Navidea Biopharmaceuticals announced that results from an investigator-initiated, comparative study of Lymphoseek (technetium Tc-99m tilmanocept) injection versus filtered Tc-99m Sulfur Colloid (fTcSC) were presented at the 2015 Society of Nuclear Medicine and Molecular Imaging (SNMMI) conference. The study measured injection site pain in patients with breast cancer undergoing lymphoscintigraphy. Results of the randomized, double-blinded trial - led by Anne Wallace, M.D., professor of surgery at University of California, San Diego School of Medicine - highlighted that fTcSC caused statistically significant greater levels of pain after injection compared to Lymphoseek.

In preparation for sentinel lymph node biopsy in breast cancer and other cancers, lymphatic pathways are mapped using a procedure called lymphoscintigraphy. "Patients often fear this procedure given the evidence of injection pain from some radiotracers," said Wallace, who is also director of the Comprehensive Breast Health Center at UC San Diego Moores Cancer Center. "This study of tilmanocept demonstrated, with patient-reported data, a significantly reduced level of post-injection associated pain compared with use of an fTcSC tracer. Along with its other desirable performance characteristics, surgeons now have a reliable tool that can potentially play an important role in improved patient comfort and management."

The poster presentation, entitled, "A Randomized Double-Blinded Comparison of Injection Site Pain of Tc-99m Tilmanocept versus Filtered Tc-99m Sulfur Colloid in Patients Undergoing Lymph Node Mapping for Breast Cancer," showed results of the randomized, double-blind clinical trial comparing post-injection site pain using fTcSC versus Lymphoseek in 52 [(27) fTcSC and (25) Lymphoseek] breast cancer patients undergoing lymphoscintigraphy. Pain was evaluated with a visual analogue scale and short form McGill Pain Questionnaire at 1, 2, 3, 4, 5, 15 and 30 minutes post-injection. Analysis of the data indicates baseline pain scores were similar between groups. At one minute post-injection, patients receiving fTcSC experienced a mean change in pain of 16.8mm (standard deviation (SD) 19.5) compared to 0.2mm (SD 7.3) in the Lymphoseek group (p =0.0002). Overall, patients receiving Lymphoseek experienced statistically significant less change in pain scores compared to patients receiving fTcSC at 1-3 minutes post-injection.

Lymphoseek injection is a U.S. Food and Drug Administration (FDA)-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. It is approved by the FDA for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

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