Zila starts phase III US trial for oral cancer test:
This article was originally published in Clinica
Zila has begun a US phase III clinical trial of its oral cancer detection product, OraTest. The trial is expected to enrol less than 4,000 high-risk patients and is anticipated to be completed in a year, once all investigator sites are active. An interim analysis will be undertaken to determine the total number of patients required in the study. In a SEC filing this month, the Phoenix, Arizona firm said that upon the trial's completion, and assuming that the clinical endpoints have been met, it would take it around 3-6 months to prepare an OraTest marketing application for submission to the FDA. According to the American Dental Association, over 30,000 people are diagnosed with oral cancer annually in the US.