Zila, Inc. has announced that it has begun its Phase III clinical trial for OraTest, its oral cancer detection drug, with the completion of a meeting of the investigators in Phoenix, Arizona.
Last week Zila reached an agreement with the United States Food and Drug Administration (FDA), under their Special Protocol Assessment (SPA) process, on the design and size of its new Phase III clinical trial for OraTest.
The investigators received two days of intensive technical training specific to the protocol that will be followed in the clinical trial.
The meeting offered an opportunity to review Investigator and Zila responsibilities under Good Clinical Practices (GCPs) and provided training in an electronic data capturing system that will provide a more timely review of enrollment progress.
Thirteen investigative sites were represented at the meeting, including Johns Hopkins University, the University of Texas, MD Anderson Cancer Center, New York University College of Dentistry, University of Illinois Medical Center, several VA Medical Centers as well as 4 sites within the Ukraine. Also represented was Quintiles, the contract research organization that is coordinating many aspects of the clinical trial.
"I am extremely pleased that we were able to bring together this prestigious group of individuals and institutions to work on our Phase III OraTest clinical trial. This day is not only a very significant milestone for Zila, but more importantly a huge step in the journey toward realizing a dramatic reduction of oral cancer deaths in the United States and around the world," said Douglas D. Burkett, Ph.D., Chairman, Chief Executive Officer and President of Zila, Inc.
The trial is expected to require fewer than 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.