Data Underscore Lymphoseek Specificity in Identifying Tumor-Draining Lymph Nodes and Utility in Cancer Diagnosis
DUBLIN, Ohio--(BUSINESS WIRE)-- Neoprobe Corporation (NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that results from a Phase II study of Lymphoseek® (Tilmanocept) have been published online in the Annals of Surgical Oncology and demonstrate the tracing agent’s ability to identify tumor-draining lymph nodes in breast cancer and melanoma patients. The publication of the multi-center clinical results was announced yesterday after market close by Dr. Stanley Leong, Chief of Cutaneous Oncology and Associate Director of the Melanoma Program at the Center for Melanoma Research and Treatment, California Pacific Medical Center. Dr. Leong was the lead author of the study.
“The data published in the surgical oncology community’s leading peer-reviewed journal further validates the clinical importance and potential utility of Lymphoseek in improving diagnosis of melanoma and breast cancer,” said Dr. Frederick O. Cope, Ph.D., Senior Vice President, Pharmaceutical Research and Clinical Development, of Neoprobe. “These data add to the wealth of knowledge on Lymphoseek and are encouraging as we prepare for the submission of the Lymphoseek NDA in the coming months.”
According to the American Cancer Society, approximately 209,000 new cases of breast cancer and 68,000 new cases of melanoma were diagnosed in the United States in 2010.1 Sentinel lymph node (SLN) mapping is a widely adopted intraoperative procedure for the identification of lymph nodes draining the pathway from a primary tumor. Despite widespread use of tracing agents, including vital blue dyes and 99mTc-labeled sulfur colloid, none of these compounds are FDA-approved for use in SLN mapping procedures.
Clinical Study Results
The study, “A Phase 2 Study of 99mTc-Tilmanocept in the Detection of Sentinel Lymph Nodes in Melanoma and Breast Cancer,” was led by Stanley P.L. Leong, M.D., Course Chair Professor of Surgery and Director Sentinel Lymph Node Program at the University of California, San Francisco School of Medicine. In the study 78 patients (47 melanoma, 31 breast cancer patients) underwent intraoperative lymphatic mapping (ILM) with Lymphoseek injection to help identify tumor draining lymph nodes. For those who underwent lymphoscintigraphy (55 patients; 70.5%), a tumor draining lymph node was identified in 94.5% of patients prior to surgery. Intraoperatively, Lymphoseek identified at least one regional lymph node in 96.2% of patients (97.9% in melanoma and 93.5% in breast cancer patients). The tissue specificity of Lymphoseek was 100% and displayed 95.1% mapping sensitivity by localizing in 173 out of 182 nodes removed during surgery.
The complete study and findings can be found on the Annals of Surgical Oncology’s Web site by visiting http://www.annsurgoncol.org/journal/10434/0/0/1524_10.1245_s10434-010-1524-z/2010/A_Phase_2_Study_of_99mTc-Tilmanocept_in_the_Detect.html. The manuscript will appear in the April or May edition of the Annals of Surgical Oncology.
Lymphoseek is a proprietary radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure referred to as Intraoperative Lymphatic Mapping (ILM). All of the tracing agents that are currently used in ILM are used “off label” (i.e., not specifically cleared by regulatory authorities for that intended use), and Neoprobe believes there is a need for agents with a faster injection site clearance and less pass through from the primary node to distal nodes. If approved, Lymphoseek will be the first and only radio-labeled tracing agent specifically noted for ILM. Additionally, Lymphoseek is being used investigatively for ILM in head & neck cancer. Additional information about Lymphoseek can be found at www.neoprobe.com/Lymphoseek and at www.clinicaltrials.gov.
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
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1 American Cancer Society: Cancer Facts and Figures 2010. Accessed on 2/4/11: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-026238.pdf
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