ZILA..Johns Hopkins Researchers Report Zila's OraTest(R) Product
Detects Early Cancerous and Pre-Cancerous Genetic Changes
PHOENIX, July 9 /PRNewswire/ -- Zila Professional Pharmaceuticals, a
division of Zila, Inc. (Nasdaq: ZILA), international provider of healthcare
and biotechnology products and services for dental/medical professionals and
consumers, announced publication in the American Association for Cancer
Research's Journal of Clinical Cancer Research (July 2001) of an article by
Johns Hopkins University cancer experts demonstrating that Zila's OraTest(R)
product "represents a powerful method to detect cancers as well as lesions
that are likely to progress to cancer." The research team was headed by Dr.
David Sidransky, Director of the university's Head & Neck Cancer Research
Center and a world-renown genetics expert.
Going beyond traditional microscopic examination of biopsied tissue, the
researchers conducted sophisticated lab tests in search of gene deletions --
irreversible cellular mutations that are known to be precursors of cancer.
"Genetic alterations are the hallmark of human cancer," they write. OraTest
"can detect clinically occult [unobservable] lesions in the progression
pathway to oral cancer. Remarkably, the vast majority of other lesions
[detected with OraTest] appeared normal under the microscope, but still
harbored the critical clonal genetic changes that are necessary for cancer
progression."
The Johns Hopkins team obtained oral biopsy tissue collected in a prior
OraTest clinical study from 46 cancer patients; some of the data from the
earlier study was presented to an FDA advisory panel in January 1999. Some
witnesses who appeared before that panel questioned the accuracy of the
OraTest product, suggesting that in many instances the product (a mouthrinse
sequence) stained healthy cells blue, producing false positive evaluations.
The Johns Hopkins experts, using more sophisticated lab testing, directly
addressed the accuracy issue: "In the initial [pre-1999] multi-institutional
OraTest study, investigators identified cancer in only one third of the
96 biopsied lesions. Our molecular analysis now definitively shows that three
quarters of the lesions identified by OraTest are in fact clonal [potentially
cancerous]. This study establishes the fact that preneoplastic [precancerous]
changes identified by OraTest in this patient population are often clonal and
are therefore in the progression pathway to cancer. Accumulating evidence
suggests that these clonal patches place these patients in a very high risk
category."
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