Navidea Biopharmaceuticals has jouned forces with Maimonides Medical Centre to investigate Lymphoseek injections as a potential treatment for colorectal cancer.
Dr. Danny Sherwinter, surgeon and the director of the Department of Minimally Invasive and Bariatric Surgery at Maimonides Medical Centre in Brooklyn, New York, will be in charge of the investigator-initiated clinical study.
Enrolment of the open-label evaluation is expected to begin in early 2013, including the assessment of lymph nodes from a maximum of 40 colon cancer subjects using lab equipment.
At the moment, the standard approach to lymph node assessment in colorectal cancer is to take out the full lymph node basin, leaving a large number of lymph nodes for pathology analysis.
While interest in lymphatic mapping is on the rise, broad application is affected by limitations in current technology.
However, results from phase III studies show that Lymphoseek has performance advantages well suited to lymphatic mapping in settings such as colorectal cancer.
Dr Sherwinter explained: "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.
"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."
Mark Pykett, Navidea’s president and chief executive, believes that the study represents an "important step forward" in advancing Lymphoseek's medical and market potential.
"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."
News of this latest trial comes after Navidea finished clinical research into the Radiopharmaceutical agent NAV 4694.
Cornelia Reininger, Navidea's chief medical officer, explained that the results represent "exciting progress".
