ZILA Zila (MM)

Zila, Inc., (Nasdaq: ZILA), has enrolled the first patients in its Phase III clinical trial for OraTest, its oral cancer detection drug. Zila began its new Phase III clinical trial after reaching an agreement under the United States Food and Drug Administration's Special Protocol Assessment process. The trial is expected to require fewer than 4,000 high-risk, readily available patients, generally requiring a single visit and will be conducted at approximately 13 investigative sites, 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. Quintiles, a contract research organization, is coordinating many aspects of the clinical trial. "We are excited that this long awaited clinical trial has begun in earnest with the enrollment of our first patients," said Douglas D. Burkett, Ph.D., Chairman, Chief Executive Officer and President of Zila, Inc. "The current method of oral cancer detection is a visual head and neck exam, which results in late detection of almost 70 percent of oral cancers and a low 5-year survival rate. The beginning of patient enrollment in the OraTest clinical trial brings us closer to our goal of improving the survivability of oral cancer by detecting the disease early." The trial is expected to require approximately a year for completion, once all investigator sites are active, but will include an interim analysis to determine the total number of patients required. About OraTest OraTest is a rinse for detecting pre-cancer and cancer in patients at elevated risk for oral cancer, applied as a chair-side oral rinse and swab and administered by either a dentist or medical practitioner. OraTest has been reported to be both highly sensitive and specific to cancer and pre-cancer cells within the mouth that may not be otherwise visible. About Oral Cancer Americans die at the rate of one per hour from oral cancer. According to statistics published by the American Dental Association, more than 30,000 people are diagnosed with this deadly disease each year in the U.S., making the frequency of oral cancer greater than cervical, brain or ovarian cancers. Approximately 50 percent of patients diagnosed with oral cancer will die within five years, because almost 70 percent of all oral cancer cases are diagnosed in the later stages. However, with early detection, oral cancer has an 80 percent five-year survival rate, according to the American Cancer Society. More than 25 percent of oral cancer victims have no predisposing risk factors. Those generally considered at risk are: -- Age 40+ -- Users of smoking or chewing tobacco within the past 10 years -- Consumers of one or more alcoholic drinks daily, including one beer, one glass of wine or one drink of spirits Any combination of these factors significantly increases oral cancer risk. 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 Zila Tolonium Chloride and OraTest(R) technologies. -- Zila Pharmaceuticals, marketer of products to promote oral health and prevent oral disease, including ViziLite(R) Plus oral lesion identification kits and Peridex(R) prescription periodontal rinse. -- Zila Nutraceuticals, manufacturer and marketer of Ester-C(R) and Ester-E(TM), branded, highly effective forms of Advanced Protection vitamins C and E. For more information about Zila, visit www.zila.com. This press release contains forward-looking statements within the meaning of Section 27A of the 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, margins, profitability, cash flows and capital needs, the ability of the Company to maintain required cash flows and cash availability to implement its business plan and appreciation in the market value of Zila's common stock. Such factors include, but are not limited to: increased competition from current competitors and new market entrants; the Company's ability to maintain, expand, or in certain cases, regain distribution within new or existing channels of trade for its products and changes in positions currently taken by regulators. There can be no assurance that the forward-looking statements contained in this press release 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 Report on Form 10-K for its fiscal year ended July 31, 2005, filed with the Securities and Exchange Commission.