99mTc-Tilmanocept for Sentinel Lymph Node Biopsy in Cervical Cancer Surgeries

DESCRIPTION provided by applicant Navidea Biopharmaceuticals Navidea is seeking SBIR FastTrack grant support to investigate the clinical utility safety and efficacy of its new product mTc tilmanocept to identify sentinel lymph nodes SLNs during surgeries to remove early stage cervical cancers with the intent of improving patient outcomes and reducing post surgical morbidities in patients undergoing these operations Cancer patients can frequently be cured of their illnesses by surgeries that remove their tumors To be successful these surgeries must remove all of a patientandapos s cancer Residual tumor tissue in patients after surgery can result in potentially life threatening disease recurrences It is very common that the first places to which a cancer may spread metastasize beyond the primary tumor are to lymph nodes that are immediately downstream from the tumor in the lymphatic flow the SLNs Previously and or currently it is was standard of care in cervical cancer surgeries to remove e lymph nodes and examine these lymph nodes for the presence of cancer This surgical strategy presumably removes any lymph node metastases and provides important disease staging information that guides postsurgical treatment decisions However wholesale lymph node removal frequently causes patients to develop lymphedema a serious post surgical complication among other morbidities Alternatively a surgeon can identify the SLNs If the SLNs are free of cancer it is very unlikely that cancer has spread to other lymph nodes further downstream in the lymphatic drainage pathways Patients with cancer free correctly identified SLNs can be spared from extensive node removal frequently avoiding serious post surgical morbidities A particular concern in using SLN mapping in cervical cancer patients is that because of the anatomical position of the cervix lymphatic drainage proceeds bilaterally In order to be effective SLNs must be detected bilaterally in cervical cancer surgeries for SLN identification to be considered complete and adequate Current competitors of mTc tilmanocept cannot identify SLNs bilaterally in of cases With the proposed study Navidea is initiating efforts to evaluate mTc tilmanoceptandapos s SLN identification performance in cervical cancer surgeries Ultimately the goal of this project is to amend the mTc tilmanocept New Drug Application NDA to include an indication for lymphatic mapping in cervical cancer surgeries thus permitting the benefits of mTc tilmanocept to be extended to cervical cancer patients The proposed study is designed as an open label within patient study of mTc tilmanocept and an alternative mapping agent Lymphazurin R for detection of nodes in patients with cervical cancer The study will determine how well SLN identification with Lymphazurin and mTc tilmanocept compare with each other Additionally the SLN pathology the global gold standard for false negative rates will be contrasted between agents and between the pathology of all nodes that may be removed during the procedure non SLNs The study will also focus on the ability of mTc tilmanocept to facilitate detection of SLNs bilaterally The study will involve patients and last yrs PUBLIC HEALTH RELEVANCE Lymphatic mapping and the sentinel lymph node theory have very significantly improved quality of care and patient outcomes in patients being surgically treated for early stage breast cancers melanoma and head andamp neck squamous cell carcinoma with virtually no increase in recurrent disease risk as this risk relates to regional metastasis mTc tilmanocept Lymphoseek R is a proven superior lymphatic mapping agent in these cancer types Navidea Biopharmaceuticals is initiating efforts to investigate the performance of mTc tilmanocept in cervical cancer with the intent of extending the benefits of lymphatic mapping with mTc tilmanocept to patients undergoing surgeries to remove early stage cervical cancers