Oral cancers don’t get a lot of mainstream attention because they aren’t among the deadliest cancers by sheer numbers. They do, however, carry a surprisingly high mortality rate: between 40 and 50 percent of people diagnosed with an oral cancer die within five years.
The problem, according to the Oral Cancer Foundation, is that they’re usually diagnosed late-stage, when the cancer has already spread.
Vigilant Biosciences wants to change that and has just collected $2.3 million to help it along.
The company is developing a low-cost kit for assessing a person’s risk of oral cancer before any lesions appear in the mouth. The kit comprises a teaspoon of saline solution, a collection cup and a testing strip. A person swishes the solution around in her mouth and gargles it for about ten seconds, then spits it into the collection cup. The test trip is inserted into the cup, and if early-stage cancer is detected, the strip changes color within 10 minutes.
The color change is triggered by certain levels of proteins that scientific co-founder Dr. Elizabeth Franzmann showed were early indicators of squamous cell carcinoma, the most common oral cancer. Franzmann is a professor of otolaryngology at University of Miami, where the screening test has been developed and tested.
So far in clinical trials at the university, the biomarkers have shown 80-85 percent sensitivity and 88-100 percent specificity, according to Vigilant’s website.
To continue moving toward a 510(k) clearance and CE Mark approval, the company just closed an oversubscribed $2 million Series A, as well as a $300,000 loan from the Florida Institute for the Commercialization of Public Research’s Seed Capital Acceleration Program. The company is targeting initial commercial sales in 2015.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The intent, according to Vigilant’s website, is for the screening kit to be used at dentist offices or public health screening facilities, with an emphasis on tobacco users, people who consumer alcohol and people with HPV – all of which increase a person’s risk for oral cancer.
Entrepreneur and intellectual property lawyer Matthew Kim formed Vigilant in 2011. Kim, who previously founded an aerosol therapeutics company called AerovectRx, was inspired to start Vigilant by his parents, who are both oral cancer survivors.
