London, England � Zila Europe, a division of Zila, Inc. (Nasdaq: ZILA), international provider of healthcare and biotechnology products and services for dental/medical professionals and consumers, announced that the British Ministry of Defense (MoD) will conduct a mouth cancer screening trial using Zila Europe�s OraTest� oral cancer detection product. Of the Ministry�s roughly 200,000 personnel, 8-10,000 at-risk individuals (age 45 and older, smokers or drinkers) are expected to be examined with the OraTest product; some portion of those will be referred for biopsy and possible surgery. The trial will be officially launched during the first annual U.K. Mouth Cancer Awareness Week, which begins 11 November 2001.
MoD consultant head and neck specialist, Surgeon Commander D. K. Riden, RN FDSRCS, FRCS, FRCS (OMFS), who is based at the Royal Hospital Haslar, said the objectives of the trial are to gauge the efficacy of the OraTest product in the hands of the MoD�s general dental practitioners, and ensure that proper and efficient referral pathways are in place so that all personnel can be examined and treated in a timely fashion. �If the trial is successful, we would strongly recommend implementation of Ministry-wide annual OraTest screening for all at-risk personnel,� Surg Cdr Riden said.
In the trial, the OraTest product, which is being donated by Zila Europe, will be used by MoD dentists at some 200 dental facilities at 19 military centres -- 14 in the U.K., four in Germany and one in Cyprus. MoD dentists are general practitioners, either employees of the armed services or civilian practitioners working under contract. All MoD dentists currently do full head, neck and soft tissue examinations, and every member of the armed forces is required to visit the dentist at least once a year. �Compliance with trial protocols will obviously not be an issue,� Surg Cdr Riden noted.
At the present time, virtually all MoD personnel with suspicious oral lesions are referred to Royal Hospital Haslar for biopsy and possible surgery. For control purposes during the trial, all OraTest referral patients will be sent to Surg Cdr Riden.
Adrian Webber, vice president and general manager of Zila Europe, observed, �This will be the largest OraTest trial ever conducted, focusing on the utility of the product in the hands of the general practitioner. We are delighted with the decision of the MoD to undertake this trial.�
The OraTest product is a patented five-minute mouthrinse sequence that has been shown to be 100 percent sensitive for squamous cell carcinoma (the most common type of mouth cancer). It is approved for use in the U.K. for screening, detection of second primary lesions, and defining margins of lesions for biopsy and surgery. The dentist administers the OraTest product by having patients rinse with a series of three solutions and water. This stains suspicious lesions deep blue, for evaluation by the clinician, and referral to a specialist as necessary.
1 October 2001 Contact: Adrian Webber 01722 412312For Company information, visit www.zila.com.
(In the United States, OraTest is the subject of a Phase III clinical trial, and is not commercially available.)
This document contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based largely on Zila's expectations or forecasts of future events, can be affected by inaccurate assumptions and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the Company's control. Therefore, actual results could differ materially from the forward-looking statements contained herein. A wide variety of factors could cause or contribute to such differences and could adversely impact revenues, profitability, cash flows and capital needs. There can be no assurance that the forward-looking statements contained in this document will, in fact, transpire or prove to be accurate. For a more detailed description of these and other cautionary factors that may affect Zila's future results, please refer to Zila's annual report on Form 10-K for its fiscal year ended July 31, 2000, and its quarterly report on Form 10-Q for the quarter ended April 30, 2001, filed with the U.S. Securities and Exchange Commission.