Zila has begun a Phase III clinical trial for OraTest, its oral cancer detection drug. The trial will enroll approximately 4,000 high-risk, readily available patients, generally requiring a single visit. The trial is expected to require approximately one year for completion, once all investigator sites are active, but will include an interim analysis to determine the total number of patients required.
More than 30,000 people are diagnosed with oral cancer each year in the U.S., making the frequency of oral cancer greater than cervical, brain or ovarian cancers. More than 50 percent of patients diagnosed with oral cancer will die within five years, because almost 70 percent of all oral cancer cases are diagnosed in the later stages.