ZILA Zila (MM)

Zila, Inc. (Nasdaq:ZILA) commented on a recent journal article in which the authors address the potential efficacy of toluidine blue in identifying high-risk oral pre-malignant lesions. In response to a number of inquiries, Douglas D. Burkett, Ph.D., Zila's Chairman, President and CEO, confirmed that the article indicates that the toluidine blue used in the Canadian study is the Company's proprietary Zila(R) Tolonium Chloride (ZTC(TM)). This patented pharmaceutical-grade form of toluidine blue has not been approved by the FDA for the identification of oral pre-malignant lesions; however, Zila is in the process of initiating a new clinical trial for the purpose of gaining FDA approval of ZTC for the detection of oral pre-cancer and cancer. "While we remain steadfast in our Company policy of not commenting with respect to pending FDA-related matters, I found it necessary to address the many questions related to the Canadian study," stated Dr. Burkett. In the independent study, funded by the National Institutes of Health (NIH), 100 patients with oral lesions but without any history of oral cancer were monitored for an average of 44 months in order to evaluate the potential use of toluidine blue in identifying high-risk oral pre-malignant lesions. The study's authors found a statistically significant elevation in cancer risk among patients with toluidine blue positive lesions and suggested that the results indicate the potential use of toluidine blue in identifying high-risk oral pre-malignant lesions. Reprints of "Toluidine Blue Staining Identifies High-Risk Primary Oral Premalignant Lesions with Poor Outcome" are available from the Cancer Control Research Program, British Columbia Cancer Research Centre, Room 3-113, 675 West 10th Avenue, Vancouver, British Columbia, Canada V5Z 1L3. About Zila Zila, Inc., headquartered in Phoenix, is an innovator in preventative healthcare technologies and products, focusing on enhanced body defense and the detection of pre-disease states. Zila has three business units: -- Zila Biotechnology, a research, development and licensing business specializing in pre-cancer/cancer detection through its patented ZTC(TM) and OraTest(R) technologies. -- Zila Pharmaceuticals, marketer of products to promote oral health and prevent oral disease, including ViziLite(R) oral examination kits and Peridex(R) prescription periodontal rinse. -- Zila Nutraceuticals, manufacturer and marketer of Ester-C(R) and Ester-E(R), branded, highly effective forms of Advanced Protection vitamins C and E. For more information about Zila, visit www.zila.com.