Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, has entered into an agreement to collaborate with Maimonides Medical Centre to investigate the utility of Lymphoseek (technetium Tc 99m tilmanocept) Injection in lymphatic mapping procedures for colorectal cancer. 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.

Dr Danny Sherwinter, surgeon and the director of the Department of Minimally Invasive & Bariatric Surgery at Maimonides Medical Centre in Brooklyn, New York, will lead the investigator-initiated clinical study.

"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 localisation 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."

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule, investigational radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage cancers such as breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumour, which have the highest probability of harboring cancer.

Lymphatic mapping is a procedure in which lymph nodes that may contain tumour metastases are identified and biopsied to determine if cancer has spread beyond the primary tumour. Accurate staging of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence.

Lymphatic mapping is a procedure designed to guide lymph node dissection and biopsy procedures. It consists of Intraoperative Lymphatic Mapping (ILM) often accompanied by lymphoscintigraphy. Lymphoscintigraphy is an imaging procedure routinely performed pre-operatively to provide guidance on the location of lymph nodes to be biopsied. ILM is a surgical procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. These nodes, commonly referred to as “Sentinel Lymph Nodes,” are removed and analyzed for the presence of malignant cells. Lymphatic Mapping provides an accurate staging procedure that can help ensure optimal surgical and therapeutic choices, including the avoidance of the morbidity of a complete lymph node dissection for patients in whom the Sentinel Lymph Nodes were found to be free of cancer.