ImClone Systems Inc (formerly IMCL)

[Telephonics]

Zila Inc. Product Selected to Identify Pre-Cancer in Study of Leading Cancer Treatment Chemotherapeutic - ERBITUX
Tuesday September 4, 7:35 am ET
- ViziLite Plus with TBlue630 -


PHOENIX, Sept. 4 /PRNewswire-FirstCall/ -- Zila, Inc.'s (Nasdaq: ZILA - News) ViziLite® Plus with Tblue630(TM) screening system for early detection of abnormalities which can lead to oral cancer, has been selected to identify pre-cancerous lesions in a Phase II study of Cetuximab (ERBITUX®), a leading cancer therapeutic for head and neck cancer developed by ImClone Systems (Nasdaq: IMCL - News) and distributed by Bristol-Meyers Squibb (NYSE: BMY - News).
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The NIH has awarded a Specialized Program of Research Excellence (SPORE) grant for the study. The primary objective of the clinical trial is to evaluate ERBITUX efficacy in treating upper aerodigestive pre-cancer. ERBITUX is currently marketed for the treatment of head and neck cancer (including upper aerodigestive) as well as metastatic colorectal cancer.

Dr. Frank J.Bellizzi, President of Zila Pharmaceuticals, "We are pleased that Zila's ViziLite Plus with Tblue630 has been selected for use in this clinical trial. The use of ViziLite Plus in such an important study with the leading head and neck cancer therapeutic demonstrates its growing reputation as the premier oral cancer screening technology."

The coordinating center for the study is The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. The Protocol Chairman is Joseph Califano, M.D., of the Department of Otolaryngology-Head and Neck Surgery.

Over 30 clinical investigators at key academic research institutions and cancer research centers are scheduled to participate in the study. The Phase II study is anticipated to enroll and evaluate approximately 60 patients over a three-year period. Patients will be evaluated clinically and biopsies will be taken pre- and post-treatment. The biopsies will be analyzed histopathologically, but will also be analyzed for genetic changes using Zila's proprietary LOH assay. The assay is the only validated method for identifying biomarkers consistent with oral premalignencies and oral cancer.

About ViziLite® Plus

ViziLite® Plus is an oral screening technology that utilizes ViziLite, an advanced chemiluminescent light technology, with Tblue630. The Tblue630 marking system employs Zila Tolonium Chloride (ZTC(TM)), the only patented pharmaceutical-grade form of toluidine blue in an FDA-cleared device.

For more information about ViziLite Plus, visit http://www.vizilite.com.

About Zila's LOH Assay

Biopsies are traditionally analyzed histopathologically to determine the histological changes in diseased tissue and enable classification of the tissue such as benign, dysplastic or cancerous. Leading cancer centers now recognize the value of also evaluating the DNA of biopsy samples for markers that signal that tissue is on the progression pathway to cancer. Zila has developed a proprietary DNA assay that evaluates chromosomal deletions by determining the loss of heterozygosity (LOH) of such biopsies. The validated LOH assay is utilized in the Zila OraTest Phase III clinical trial as well as the Erbitux Study, and the Company is evaluating commercial opportunities for the test.

About Zila, Inc.

Zila, Inc., headquartered in Phoenix, is an oral cancer screening company focused on the prevention and treatment of oral disease. Zila is dedicated to establishing ViziLite® Plus as the new standard of care for the early detection of oral abnormalities that could lead to cancer, with an initial focus on the dental market through Pro-Dentec®, a leading designer, manufacturer and marketer of Soft Tissue Management (STM®) products. Sold exclusively and directly to dental professionals, Pro-Dentec's core products include the Rota-dent® Professional Powered Brush, the Pro-Select3® Piezo-Ultrasonic Scaler System and a suite of pharmaceutical STM® products for both in-office and home-care use.

For more information about Zila, visit http://www.zila.com.