Zila Inc. Product Selected to Identify Pre-Cancer in Study of Leading Cancer Treatment Chemotherapeutic - ERBITUX
September 04 2007 - 7:35AM
PR Newswire (US)
- ViziLite Plus with TBlue630 - PHOENIX, Sept. 4
/PRNewswire-FirstCall/ -- Zila, Inc.'s (NASDAQ:ZILA) ViziLite(R)
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(R)), a leading cancer therapeutic for head and neck cancer
developed by ImClone Systems (NASDAQ:IMCL) and distributed by
Bristol-Meyers Squibb (NYSE:BMY). 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(R) Plus ViziLite(R) 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(R) 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(R), a leading designer, manufacturer and marketer of
Soft Tissue Management (STM(R)) products. Sold exclusively and
directly to dental professionals, Pro-Dentec's core products
include the Rota-dent(R) Professional Powered Brush, the
Pro-Select3(R) Piezo-Ultrasonic Scaler System and a suite of
pharmaceutical STM(R) products for both in-office and home-care
use. For more information about Zila, visit http://www.zila.com/.
DATASOURCE: Zila, Inc. CONTACT: Robert Jaffe of PondelWilkinson,
Inc., +1-310-279-5969, for Zila, Inc. Web site:
http://www.zila.com/
Copyright
Zila (NASDAQ:ZILA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Zila (NASDAQ:ZILA)
Historical Stock Chart
From Jul 2023 to Jul 2024