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February 4, 2013
09:27 EDTNAVBNavidea announces collaboration with Maimonides Medical Center
Navidea Biopharmaceuticals has entered into an agreement to collaborate with Maimonides Medical Center to investigate the utility of Lymphoseek Injection in lymphatic mapping procedures for colorectal cancer. Dr. Danny Sherwinter, surgeon and the Director of the Department of Minimally Invasive & Bariatric Surgery at Maimonides Medical Center in Brooklyn, NY, will lead the investigator-initiated clinical study. This open-label evaluation, expected to start enrollment in early 2013, will be performed at Maimondes and will include the assessment of lymph nodes from up to 40 colon cancer subjects. According to the American Cancer Society, approximately 140,000 new cases of colorectal cancer are expected to be diagnosed in the United States annually1 while worldwide annual diagnosis is over 1.2 million.
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March 25, 2015
07:32 EDTNAVBNavidea to present Lymphoseek injection data at SSO meeting
Navidea Biopharmaceuticals announced that data from its Lymphoseek injection studies in melanoma, breast and oral cavity squamous cell cancers will be presented at the 68th Annual Cancer Symposium of the Society of Surgical Oncology meeting held in Houston, TX, March 25-28. An oral presentation by Douglas Chepeha, M.D. of the University of Toronto-Princess Margaret Hospital reveals that analysis from Phase 3 data for detection of sentinel lymph nodes in head and neck oral cavity squamous cell carcinoma patients demonstrated high concordance between preoperative lymphoscintigraphy and intraoperative SLN biopsy findings. Notably, 95.2% of patients had agreement between their preoperative and intraoperative findings. This high concordance when using Lymphoseek confirms its role in the utility of preoperative lymphoscintigraphy imaging for planning and conducting SLN biopsy. Results of a follow-up outcome study presented as a poster by Julian Kim, M.D. of the University Hospitals Seidman Cancer Center indicated that in patients who were confirmed to be node-negative after sentinel lymph node biopsy the regional recurrence-free ratewas 98.8% at three years. An overall false negative rate for the two tumor types was 5.6% and the negative predictive value was 98.6%. These results demonstrate that Lymphoseek accurately identified SLNs and is likely predictive of pathological staging.

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