Vigilant Biosciences, Inc., (“Vigilant”), a leading innovator and developer of solutions that aid in the early detection and intervention of cancer, , today announced the completion of a National Cancer Institute (NCI) sponsored clinical study of new technology designed to aid clinicians in the early detection of oral cancer, developed at the University of Miami Miller School of Medicine and exclusively licensed to Vigilant.
The study of 300 subjects used a case-control design that ensured cases (oral cancer patients) and controls (volunteers without cancer) were similar with respect to other important factors such as tobacco and alcohol use, age and race. This is the largest oral cancer marker study of its kind in the U.S. The principal investigator of the study is Elizabeth Franzmann, M.D., associate professor of otolaryngology, at the University of Miami Miller School of Medicine.
“The goal of the study was to determine whether the markers could effectively distinguish individuals with oral cancer from those without cancer. Based on preliminary results, we have met our end points and look forward to publishing the results,” said Dr. Franzmann, who is also a member of the Sylvester Comprehensive Cancer Center.
Based on early study results, which will be submitted to a peer-reviewed medical journal for publication, the Company is pursuing product development and seeking investment capital.
“We are very pleased with the progress made by Dr. Franzmann in completing this landmark NCI-sponsored study,” said Matthew H.J. Kim, Founder, Chairman, and CEO of Vigilant Biosciences.“Now that the study has established feasibility of the technology, we are moving forward with product commercialization and executing on a plan for U.S. and international regulatory approval.”
The product consists of a low-cost, oral cancer-specific oral rinse test strip that provides an immediate and simple color change in the presence of certain levels of proteins clinically proven to be associated with early onset of oral cancer – typically before a lesion is even visually detected with a screening aid. Dental offices and public health screening facilities are seen as primary initial markets for the technology. The test targets smokers, drinkers and people with human papillomavirus (HPV), and initially represents an approximately $600 million U.S. market opportunity and a multibillion dollar opportunity worldwide.
About 640,000 people are diagnosed with oral cancer each year worldwide, according to the Oral Cancer Foundation. In the United States, about 35,000 new cases each year result in about 6,800 deaths, according to the American Cancer Society. Oral cancer treatment options include surgery, radiation and chemotherapy.
About Vigilant Biosciences, Inc.
Vigilant Biosciences is a leading innovator and developer of solutions that aid clinicians in the early detection and intervention of cancer. Vigilant’s initial product development initiatives include rapid and lab-based products that are simple, accurate and cost-effective, and empower healthcare practitioners to improve lives through earlier intervention. For more information, visit www.vigilantbiosciences.com.