Vigilant Biosciences — Department of Health and Human Services SBIR Phase I: NIDCR

Description

DESCRIPTION provided by applicant Oral squamous cell carcinomas including those of the mouth and oropharynx comprise more than of all cancers affecting these tissues Of all the major cancers oral cancer has one of the worst five year survival rates of Historically the death rate associated with this cancer is particularly high because it is discovered late stage III or IV often when it has spread to the lymph nodes or deeper structures Late stage cancers have high mortality are expensive to treat and have high morbidity The current andquot gold standardandquot for oral cancer diagnosis is a physical and visual examination followed by biopsy Unfortunately due to delays in diagnosis most cases are diagnosed in late stage with a survival rate around even after aggressive treatment regimens including combinations of radiation surgery and chemotherapy However if diagnosed early stage I II the five year survival rate can be as high as representing a significant healthcare cost savings Thus there is a pressing need for an improved oral cancer early detection test which will save lives improve clinical outcome and reduce treatment costs We have developed a unique easy to use oral cancer specific rapid lateral flow point of care POC test based on the tumor initiating marker CD and total protein that accurately assesses patientandapos s risk for oral cancer The OncAlert lateral flow test strip identifies those individuals a most risk of harboring early or developing oral cancer from the million tobacco and alcohol users However often these early lesions can be invisible to the naked eye so the test strip alone will not indicate where the abnormal cells are in cases of very early disease To answer this pressing medical need in this application we will develop an imaging device that will involve a simple rinse and spit solution with an antiCD probe bound to non absorbable microspheres that will bind to cells expressing abnormally high levels of CD The bound probe can then be visualized by shining a light of specific wavelength so that very early lesions can be identified If successful this is expected to enable early detection and intervention of orl cancer even be fore visual symptoms are revealed thus addressing a crucial clinically unmet need We will carry out the fol lowing specific aims in Specific Aim we will test an in vitro model for detecting CD elevated cells using fluorescent probes on membranes We will determine whether this potential imaging agent recognizes CD on the surface of cells To do this we will culture well characterized cell lines that have been engineered to overexpress or underexpress CD In Specific Aim we will test the system in tumor explants from humans We will determine how well the conjugate identifies carcinogenesis in humans We will use human up per aero digestive tract specimens ex vivo immediately following surgical resection We will analyze oral cancer tissues with surrounding normal margin and patient tissues that were excised for benign conditions chronic tonsillitis using the anti CD fluorescently labeled beads PUBLIC HEALTH RELEVANCE Oral squamous cell carcinomas comprise more than of all cancers affecting these tissues and have one of the worst five year survival rates because they are discovered late stage III or IV often after spreading to the lymph nodes or deeper structures In this program we propose to develop an imaging device that will include a simple rinse and spit solution with an antiCD probe bound to non absorbable microspheres adhered to a fluorescent label that would permit visualization of the lesion location and improve treatment