Navidea, NIH diagnostic news
Navidea said NIH's NCI awarded the biotech a Small Business Innovation Research (SBIR) contract for up to $1.7 million over two and a half years to evaluate Lymphoseek tilmanocept in women with cervical cancer. The company will use the funds to conduct an open-label trial evaluating Lymphoseek's ability to detect lymph nodes in patients with cervical cancer. The first six-month funding segment of $165,917 has been received and will be used to identify and qualify trial sites and secure necessary contracts and Institutional Review Board approvals. The second funding segment for up to $1.5 million will be used to accrue patients, perform the sentinel lymph node procedures and pathology evaluations and perform data analyses.
In June, FDA approved an sNDA for Lymphoseek for sentinel lymph node detection in patients with squamous cell carcinoma of the head and neck (SCCHN). Another sNDA for Lymphoseek is under FDA review to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities, with an Oct. 16 PDUFA date. The product has Orphan Drug designation in the U.S. to detect sentinel lymph nodes in patients with cancer of the head and neck. ...