Meta-analysis of Navidea Biopharmaceuticals Lymphoseek® Phase 3 Data Compared to Standard of Care Techniques Published in Conjunction with the ASCO Annual Meeting

Loading...
Loading...
Navidea Biopharmaceuticals, Inc.
NAVB
today announced that the abstract reviewing a meta-analysis of Phase 3 clinical trial for Intraoperative lymphatic mapping (ILM) of lymph nodes in breast cancer, compared to standard of care techniques has been published in conjunction with the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO). The abstract entitled, “The novel receptor targeted (CD206) 99mTc-labeled tilmanocept versus the currently employed Tc99m-sulfur colloid in intraoperative lymphatic mapping (ILM) on key performance metrics in breast cancer” is published in the Journal of Clinical Oncology Online 2012; e21066. ILM is a critical technique in the assessment and removal of solid tumors, such as a breast cancer, and utilizes the injection of a color agent and/or a radiopharmaceutical imaging agent. These agents are tracked during surgery, either visually or with a gamma-detection probe. ILM is designed to aid the surgeon in identifying lymph nodes that may have a connection to the primary tumor. In the U.S., ILM employs a non-standard radiopharmaceutical agent known as Sulfur-colloid (TcSC) which was recently approved by the FDA for breast cancer ILM based on a literature review. In contrast, Lymphoseek was studied in two prospective Phase 3 trials which compared Lymphoseek to vital blue dye (VBD), the same color agent utilized in the FDA assessment of TcSC. The comparison of Lymphoseek versus TcSC plus VBD using a meta-analysis and pooled analysis, was based on the TcSC FDA review document, and focused on two functional endpoints. These were the Localization Rate which is the percentage of patients with one or more radio-detected nodes and the Degree of Localization which is the number of radio-detected nodes per patient. Both of these metrics help define the potential for an imaging agent's performance in ILM and the potential identification of metastasis to other nodes. The Localization Rate for TcSC/VBD was 94% and for Lymphoseek it was significantly greater at 99.91% by meta-analysis and 98.65% by pooled analysis (p<0.0001 and p<0.008, respectively). The Degree of Localization derived from the publication data base for TcSC was 1.6 nodes per patient and for Lymphoseek it was 2.08 per patient by meta-analysis and 2.16 per patient by pooled analysis (p<0.0001 and p<0.0001, respectively).
Loading...
Loading...
Posted In: NewsFDA
We simplify the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...