Navidea gets $1.67m fast track NIH SBIR grant to evaluate lymphoseek in cervical cancer

The multicenter, clinical study in patients with early cervical cancer will seek to assess and provide data in support of the use of Lymphoseek in sentinel lymph node biopsy (SLNB) procedures which identify and evaluate the lymph nodes most likely to harbor additional cancer.

The SBIR grant is awarded in two parts with the potential for total grant money up to a total of $1.67million over two and a half years. The first six-month funding segment of $165,917, which has already been awarded, is expected to enable Navidea to identify and qualify trial sites and secure necessary contracts and Institutional Review Board (IRB) approvals.

The second funding segment could provide for up to an additional $1.5 million to be used to accrue participants; perform the sentinel lymph node (SLN) procedures and pathology evaluations; and perform data analyses to confirm the safety and effectiveness of Lymphoseek.

"UC San Diego Moores Cancer Center played a key role in tilmanocept’s Phase 1-3 clinical evaluation for sentinel lymph node assessment in melanoma, breast cancer and squamous cell carcinoma of the head and neck," said Michael T. McHale, M.D., Associate Professor, Fellowship Director, Division of Gynecologic Oncology, UC San Diego Moores Cancer Center.

"There is currently a growing focus on sentinel lymph node biopsy (SLNB) procedures in gynecologic cancers. We are pleased to participate in this important study which will evaluate and compare the abilities of tilmanocept and an alternative detection agent to identify SLNs during cervical cancer surgery. If successful, this study could potentially advance the use of SLNB procedures in cervical cancer."

"We appreciate NCI’s support as we seek to further broaden the Lymphoseek label which is currently indicated for use in lymphatic mapping for breast cancer and melanoma, and to guide Sentinel Lymph Node Biopsy in certain head and neck cancers," said Frederick O. Cope, Ph.D., F.A.C.N., C.N.S Senior Vice President and Chief Scientific Officer of Navidea.

"The current standard of care in cervical cancer surgery is to remove in excess of 20 lymph nodes which often leads to more extensive, complex and costly surgical procedures as well as potentially to serious post-surgical complications and morbidity. By accurately and reliably identifying the first lymph nodes draining a tumor, Lymphoseek may provide surgeons important disease staging information that can guide treatment decisions and improve patient outcomes."

"This study is an excellent example of how we intend to support the expanded use of Lymphoseek to help patients afflicted with other solid tumor areas," said Michael Goldberg, M.D., Navidea Interim CEO.

"With 3-4 million new solid tumors each year in the US and Europe, this and other studies will help establish and standardize surgical methods and SLN procedures with the goal to establish Lymphoseek as a new standard of care for guiding patient treatment."

This study is designed as a multicenter, open-label, within-patient comparative study of Lymphoseek and an alternative lymphatic mapping agent referred to as vital blue dye for detection of lymph nodes in patients with cervical cancer. The study, using lymphatic mapping and SLN biopsy procedures, will compare the abilities of Lymphoseek and the alternative agent to identify SLNs during cervical cancer surgery.

Additionally, the sentinel node pathology will be contrasted between agents and between the pathology of other nodes that may be removed during the procedure (non-sentinel nodes). The study is expected to involve 40 patients and last 1.5 years.