Zila begins phase 3 trial for oral cancer detection drug OraTest

By E. Janene Geiss

Philadelphia, Dec. 13 - Zila, Inc. said Tuesday that it has begun its phase 3 clinical trial for OraTest, its oral cancer detection drug, with the completion of a meeting of the investigators and an agreement reached last week with the Food and Drug Administration.

Investigators received two days of intensive technical training specific to the FDA-approved protocol that will be followed in the clinical trial, according to a company news release.

The meeting offered an opportunity to review the responsibilities of the investigators and the company under good clinical practices and provided training in an electronic data capturing system that will provide a more timely review of enrollment progress, officials said.

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 Veterans medical centers and four sites in the Ukraine. Quintiles, the contract research organization coordinating many aspects of the trial, also was represented, officials said.

"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," Douglas D. Burkett, chairman, chief executive officer and president of Zila, said in the release.

The trial expects to enroll about 4,000 patients and take about a year to complete once all sites are active. An interim analysis also will be conducted, officials said.

Zila, based in Phoenix, is an innovator in preventative health care technologies and products, focusing on enhanced body defense and the detection of predisease states.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.