Maimonides, Navidea to evaluate Lymphoseek use in lymphatic mapping for colorectal cancer

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced it has entered into an agreement to collaborate with Maimonides Medical Center to investigate the utility of Lymphoseek (technetium Tc 99m tilmanocept) 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 annually while worldwide annual diagnosis is over 1.2 million.

"While colorectal surgeons have a strong interest in being able to more accurately pinpoint lymph nodes most likely to contain cancer from among the full draining bed of nodes removed during colorectal cancer resection, the field has been awaiting the advent of a suitable lymphatic mapping agent," commented Dr. Sherwinter. "Although efforts are growing in the use of lymph node mapping in colorectal cancer, the poor sensitivity of current agents and techniques has hindered progress in the field. Due to its receptor-targeting properties and strong performance in other malignancies such as breast and melanoma, Lymphoseek holds promise to open new opportunities in the field of lymphatic mapping in colorectal cancer."

Currently, the approach to lymph node assessment in colorectal cancer is to remove the entire lymph node basin during colon resection surgery, resulting in a large number of lymph nodes for pathology analysis. Interest in lymphatic mapping in colorectal cancer is growing however broad application is impeded by limitations in existing technology which have been associated with high false negative rates. With results from Phase III studies demonstrating its rapid injection site clearance and retained localization to key predictive lymph nodes, Lymphoseek has performance advantages that may be well suited to lymphatic mapping in settings such as colorectal cancer in an effort to reduce false negative rates and morbidity, and provide improved diagnostic accuracy.

"This study represents an important step forward in advancing Lymphoseek's medical and market potential in additional cancers where lymphatic mapping may be very useful but in which effective technologies haven't been developed," said Mark Pykett, Navidea's President and CEO. "Collaborations such as this, with innovative investigators at leading medical institutions, are part of Navidea's strategy to maximize the potential for Lymphoseek and help patients who might benefit from more precise identification of key predictive lymph nodes that harbor cancer."