Zila, Inc. (Nasdaq: ZILA) announced it will invest an additional $3 million to accelerate the on-going OraTest(R) Phase III clinical trial. The funds are a portion of the proceeds from the sale of the Company's Zila Dental Supply division, announced on Nov. 5.
Zila Technical Operations Vice President Doug Burkett, PhD, said, "The U.S. Food & Drug Administration (FDA) last year authorized a Phase III clinical trial protocol designed to process some 600 patients at 40 clinical research centers. Zila retained ILEX(TM) Oncology Services to manage this research. Operating within the limitations of our resources, we have brought centers on-line and recruited patients as funding has allowed. The investment of an additional $3 million will allow the Company to initiate additional centers and recruit patients at a faster rate, with the objective of shortening the time to presentation of the new data to the FDA."
Researchers at the Johns Hopkins Head & Neck Cancer Research Center, led by Center Director and renown cancer geneticist Dr. David Sidransky, reported in the Journal of Clinical Cancer Research (July 2001) that new research in genetic markers suggests that the OraTest product "represents a powerful method to detect cancers as well as lesions that are likely to progress to cancer." The OraTest product is a patented five-minute mouthrinse sequence that has been shown to be sensitive for oral squamous cell carcinoma (the most common type of mouth cancer).
Independent research completed at another major medical center suggests that components of Zila(R) Tolonium Chloride (the active ingredient in the OraTest product) may kill squamous cancer cells using a selective method of action. Utilizing a National Cancer Institute in vitro chemotherapeutic agent screening test, researchers produced impressive findings for the material. The Company has filed for patent protection related to the therapeutic application of Zila Tolonium Chloride.
Dr. Burkett said funding will be provided to begin pre-clinical research on the potential use of Zila Tolonium Chloride as a therapeutic drug for cancer. "The studies, for which protocols have already been prepared, will be short-term," Dr. Burkett said. This work may further the Company's efforts to attract drug development partners.