Vigilant Biosciences Inc, Fort Lauderdale, Fla, has received a Phase I Small Business Innovation Research (SBIR) grant in the amount of $219,454 from the National Institute of Dental and Craniofacial Research (NIDCR). The 15-month grant will fund research by Vigilant Biosciences to develop a diagnostic test that utilizes optical imaging in combination with an oral rinse to detect CD44, a tumor-initiating and stem cell-associated biomarker for oral cancer.
According to the World Health Organization, there are more than 529,000 new cases of oral (lip, oral cavity, and pharynx) cancer each year worldwide, with mortality rates reaching up to 292,000 deaths each year. Historically the death rate associated with this cancer is particularly high due to late-stage diagnosis and intervention. Currently, the vast majority of patients are detected through a visual exam or are symptomatic, at which point they are likely late stage. As a result, oral cancer often goes undetected to the point of metastasizing.
Vigilant Biosciences’ current product line is based on patented technology that measures an unprecedented combination of CD44 and total protein levels—markers clinically validated to be associated specifically with oral cancer when measured in an oral rinse—to aid clinicians in the early detection and intervention of oral cancer. The simple, oral rinse procedure is designed to be easy to administer and noninvasive for the patient.
“We are very pleased to receive this Phase I SBIR award from the NIDCR, as it supports the significance and further validation of the promise of our technology and its potential impact on cancer detection and intervention,” says Matthew H. J. Kim, founder, chairman, and CEO of Vigilant Biosciences. “The proprietary science behind our tests uses unique biomarkers that can indicate the presence of oral and oropharyngeal cancer, often before physical symptoms are present. This grant will enable us to expand our approach to additional platforms and applications to meet the critical and growing need for earlier intervention of this disease and potentially other cancers.”
The Phase I preclinical study will include in vitro work as well as human tissues from cancer patients and patients with benign disease of the throat.