Vigilant Biosciences Announces Grant Award from National Institutes of Health

June 13, 2017

Fort Lauderdale, FLA.

Vigilant Biosciences, Inc., a leading innovator and developer of solutions that aid in the early detection and intervention of cancer, today announced the that it has received an award as part of a multi-million dollar grant from the National Institutes of Health to fund research in support of a novel point of care test to improve early identification of oral and oropharyngeal cancer.

The five-year study will enroll 300 mouth and throat cancer patients and control subjects in a multi-institutional setting. Institutions participating in the study include UC San Diego (UCSD) Department of Surgery, New York University, John Hopkins and Greater Baltimore Medical Center.

“We are very pleased to receive this grant award from the National Institutes of Health, as it supports the significance of our technology and its potential impact on oral and oropharyngeal cancer detection and intervention,” said Dr. Elizabeth Franzmann, Scientific Founder and Chief Scientific Officer of Vigilant Biosciences. “The proprietary science behind our tests uses unique biomarkers that can indicate the presence of oral cancer, potentially before physical symptoms are present. This award will enable us to further validate our technology and potentially expand it to additional platforms and applications to meet the critical and growing need for earlier intervention of this disease.”

Joseph Califano, M.D., Professor of Surgery and Vice-Chief of the Division of Otolaryngology in the Department of Surgery at UCSD will serve as principal investigator for the study, and Dr. Charles Coffey, Assistant Professor of Surgery, Division of Otolaryngology at UCSD, will serve as the principal investigator at the San Diego Veterans Administration Hospital. This research is supported by the National Institutes of Health under award number R01CA204264.

“We are excited to team up with Vigilant Biosciences to conduct this important study,” said Dr. Califano. “The promise of an easy, low-cost test for head and neck cancer has the potential to benefit millions of people around the world. If validated, we see great opportunity for this product in various settings, including primary care, dental and head and neck specialty practices, where is could help identify patients at risk for mouth and throat cancer early on and improve the ability to cure this disease.”

The Vigilant Biosciences OncAlert Oral Cancer product line is based on patented technology that measures soluble CD44, a tumor-initiating and stem cell-associated biomarker, and total protein levels – markers clinically validated to be associated specifically with oral cancer – to aid clinicians in the early detection and intervention of oral cancer. The simple, oral rinse procedure is easy to administer and non-invasive for the patient. The OncAlert Oral Cancer product line, includes the OncAlert Oral Cancer RAPID Test and the OncAlert Oral Cancer LAB Test, both CE Marked and available in select markets outside the United States. Vigilant Biosciences’ accurate, cost-effective tests can benefit every adult, with particular emphasis on high-risk populations (i.e., current and former tobacco users, those who consume excessive alcohol, and people with human papillomavirus).

About 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 that reach up to 292,000 deaths each year. In the United States, more than 49,750 individuals will be diagnosed with oral cancer this year – around 132 new cases of oral cancer diagnosed each day. More than 9,750 people will die in the U.S. this year, as a result of the disease. Historically, the death rate associated with oral cancer is particularly high due to late stage diagnosis and intervention.

Currently, the vast majority of patients are detected through a visual and physical exam when symptomatic and are likely late stage.  As a result, oral cancer often goes undetected to the point of metastasizing. More than 40 percent of those diagnosed with oral cancer die within five years, due to late stage diagnosis. In contrast, early detection (stage I and II) of oral cancer yields survival rates of up to 90 percent. For those who survive oral cancer diagnosed in the later stages, the treatment is painful, debilitating and often disfiguring. In addition, patients often struggle with eating and drinking, communicating and self-image.

About the UC San Diego Department of Surgery
Established in 1965, the Department of Surgery at UC San Diego is home to more than 80 leading surgeons with specialties in open, minimally invasive and scarless surgery techniques.

The Department is committed to advancing surgical education by teaching and training the next generation of innovators; researching, testing and developing groundbreaking surgical techniques; providing superior patient care and service; and attracting a world-class faculty.

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. The Vigilant Biosciences OncAlert® Oral Cancer product line and OncAlert Labs product line include point-of-care and lab-based products and services that are simple, accurate and cost-effective and that can empower healthcare practitioners to improve potential outcomes through earlier intervention. The OncAlert Oral Cancer LAB Test and the OncAlert Oral Cancer RAPID Test are CE Marked and available in select international markets outside the U.S. The OraMarkTM Test is a Laboratory Developed Test that is only available in the U.S. exclusively through OncAlert Labs, LLC, a CLIA-certified laboratory and a member of the Vigilant Biosciences family of companies. For more information, visit www.vigilantbiosciences.com and www.oncalertlabs.com.

The University of Miami and Dr. Franzmann hold intellectual property used in the study and have the potential for financial benefit from its future commercialization.  Dr. Franzmann is the Chief Scientific Officer, consultant and an equity holder in Vigilant Biosciences, licensee of the IP used in the study.

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