SPECTROSCOPIC DYE LOCALIZATION: SENTINEL LYMPH NODES

DESCRIPTION (provided by applicant): Spectros Corporation and collaborators/consultants at Stanford University, Texas Tech U., Amersham Pharmacia Biotech, and Protein Design Labs, will continue development of a new, fluorescent contrast agent and imaging system, created to improve the accuracy of identifying sentinel lymph nodes during breast cancer surgery. The end result of Phase II will be a lymphatic-targeted optical contrast agent and real-time clinical imaging system, ready for human testing. In Phase II, the contrast agent (SPX-1 03), first synthesized in Phase I, will be optimized for brightness, tested for toxicity and mutagenicity, and synthesized under GMP protocols. The imaging system will be adapted for O.R. use, including custom lens systems and operating software. The system and agent will be tested in combination in animals, and then submitted to the FDA in preparation for human studies. The short-term goal is to create an imaging system and agent that exceed the sensitivity and specificity of the current dye and technetium methods, thus allowing for a more limited and patient-specific procedure without need for the injection of radioactive tracers. Ultimately, our long-term goal is to develop targeted agents to detect only cancerous nodes, allowing the 68 percent of patients who are node-negative to skip nodal biopsy altogether, and allow the remainder to undergo a patient-specific procedure. PROPOSED COMMERCIAL APPLICATIONS: Spectros will develop a commercial guidance system for sentinel node biopsy. Breast cancer is a leading cause of death in women, and accurate node biopsy is key to effective treatment selection and to patient survival. Over 150 K U.S. women/year are sentinel node biopsy candidates. The market for an improved lymph biopsy system is estimated at $150 MM/year. Therapeutic platform extensions to real-time imaging of prostate, colon, colon, melanoma, and lymphatic cancers are envisioned.