New External Study Demonstrates Strong Correlation of TriPath Imaging's ProEx(TM) Br Biomarkers with Risk of Breast Cancer Recur
December 12 2005 - 7:07AM
PR Newswire (US)
Results from an External Research Study Presented at San Antonio
Breast Cancer Symposium BURLINGTON, N.C., Dec. 12
/PRNewswire-FirstCall/ -- TriPath Imaging, Inc.
(NASDAQ:TPTHNASDAQ:-NASDAQ:News) today announced that data
generated from an external research study conducted at the Albany
Medical College using the Company's proprietary ProEx(TM) Br
biomarkers demonstrate a strong correlation between biomarker
reactivity and the risk of disease recurrence within five years
from initial diagnosis of early stage breast cancer. This research
study included 217 archived breast tissue specimens from a
retrospective cohort of patients with early stage breast cancer who
had been followed for a minimum of five years following initial
diagnosis. The research study included quantitative image analysis
of the ProEx Br biomarkers utilizing an early version of the
Ventana Image Analysis System (VIAS). The results of this study
were presented at the 28th Annual San Antonio Breast Cancer
Symposium held in San Antonio, Texas. In this retrospective study
of archived breast tissue samples from patients with early stage
breast cancer, researchers from Albany Medical College reported
that the rate of breast cancer recurrence within five years of
initial diagnosis was approximately 30% when archived breast tissue
tested negative for all ProEx Br biomarkers and approximately 40%
when positive for one or fewer ProEx Br biomarkers. When the
archived breast tissue tested positive for two or more of the five
ProEx Br biomarkers included in this research study, the rate of
recurrence increased to up to approximately 70%. Multivariant Cox
proportional analysis (Hazard Ratio) of the data collected in this
study indicated a two-fold increase in the calculated risk of
breast cancer recurrence within five years from initial diagnosis
when testing with two or more of the ProEx biomarkers was positive
(p value = 0.0141) as compared to the calculated risk of recurrence
when testing was negative for all ProEx Br biomarkers. In their
presentation, the researchers concluded that the ProEx Br
biomarkers provided independent prognostic information regarding
recurrence of breast cancer and that these data support the
potential utility of the ProEx Br biomarkers to risk stratify early
stage, lymph node negative breast cancer patients. Dr. Jeffrey S.
Ross, M.D., the Cyrus Strong Merrill Professor and Chair Department
of Pathology and Laboratory Medicine Albany Medical College
commented, "The ProEx Br biomarkers were straight forward and easy
to use in our laboratory during this research study. The VIAS
system was similarly easy to operate. We are encouraged with the
results of our study and plan to continue to use the ProEx Br
system in our breast cancer research program." "The results from
this external research study are consistent with those that we have
previously reported from our own internal studies in which we
retrospectively evaluated the correlation of the ProEx Br
biomarkers with the risk of breast cancer recurrence within ten
years from initial diagnosis of early stage breast cancer,"
commented Dr. Douglas Malinowski, TriPath Imaging Vice President
and Chief Scientific Officer. "As screening procedures continue to
improve, breast cancer is being detected at an earlier stage where
the tumors are relatively small and the cancer has not yet spread
to the lymph nodes. We targeted our biomarker discovery process to
identify biomarkers that would help physicians better identify
those early stage breast cancer patients who are at a higher risk
of recurrence and, therefore, may potentially benefit from more
aggressive therapy. " "We believe that the results from this new
external study, along with previously reported results from our
internal studies, provide an early indication of the utility of
these biomarkers" said Dr. Johnny Powers, Senior Vice President of
TriPath Oncology. "Given these very compelling results, we have
completed the development of a version of the ProEx Br biomarkers
for use on the Ventana BenchMark XT automated staining system. In
addition, we recently initiated a clinical trial to generate data
to support a submission to the FDA." About ProEx Br Biomarkers The
ProEx Br biomarkers are monoclonal antibodies that are designed to
detect over- expression of unique cellular proteins that are
predictive of breast cancer recurrence. These biomarkers were
selected after an exhaustive discovery and validation process
completed in 2004. For the purpose of the external research study,
the ProEx biomarkers were incorporated into Research Use Only
reagents designed to detect the over-expression of these proteins.
TriPath Imaging, Inc., headquartered in Burlington, North Carolina,
develops, manufactures, markets and sells innovative solutions to
improve the clinical management of cancer, including detection,
diagnosis, staging and treatment. TriPath Oncology, a wholly owned
subsidiary of TriPath Imaging, develops molecular diagnostic
products for malignant melanoma and cancers of the cervix, breast,
ovary and prostate. For more information on TriPath Imaging please
visit our web site at http://www.tripathimaging.com/. Investors are
cautioned that statements in this press release that are not
strictly historical statements constitute forward-looking
statements which involve risks and uncertainties that could cause
actual results and outcomes to differ materially from what is
expressed in those forward-looking statements. Such forward-looking
statements include, without limitation, those related to the
development of the ProEx Br biomarkers. Important factors that may
affect such forward-looking statements include, without limitation:
TriPath Oncology may be unable to successfully develop and
commercialize products and services when anticipated, if at all;
clinical trials may yield results for product candidates
incorporating the ProEx Br biomarkers that differ from the results
of our in-house and external research studies; TriPath Imaging's
products may not achieve or maintain market acceptance to the
degree anticipated; TriPath Imaging and TriPath Oncology's products
may not receive FDA or other required regulatory approval when
expected, if at all; and other risks detailed in TriPath Imaging's
filings with the Securities and Exchange Commission, including
those described in TriPath Imaging's Annual Report on Form 10-K for
the year ended December 31, 2004. Contact Stephen P. Hall, Chief
Financial Officer TriPath Imaging 336-290-8721 DATASOURCE: TriPath
Imaging, Inc. CONTACT: Stephen P. Hall, Chief Financial Officer,
TriPath Imaging, +1-336-290-8721 Web site:
http://www.tripathimaging.com/
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