Virologic (NASDAQ:VLGC)
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ViroLogic's eTAG(TM) System Demonstrates Potential Ability to
Predict Treatment Outcomes for Colorectal Cancer Patients
- Positive Results Indicate High Accuracy and Predictability With eTAG Assay -
HOLLYWOOD, Fla., Jan. 27 /PRNewswire-FirstCall/ -- ViroLogic, Inc.,
(NASDAQ:VLGC) announced today the presentation of clinical data assessing the
ability of the company's eTAG(TM) System to accurately predict treatment
outcomes for patients with metastatic colorectal cancer. The study, conducted
at Princess Margaret Hospital in Toronto, demonstrated that the detection of
EGF Receptor family dimers as measured by the eTAG assay correlated with
disease stability or disease progression in 18 metastatic colorectal cancer
patients being treated with erlotinib (Tarceva(R)).
The presentation is titled "Predictive value of eTAG dimerization assay in
patients with metastatic colorectal cancer treated with erlotinib," and will be
made by Carol Townsley, MD, Clinical Research fellow to Amit Oza, MD, FRCP,
Professor of Medicine, Department of Medical Oncology, Princess Margaret
Hospital, University of Toronto, working in collaboration with Lillian Siu, MD,
FRCPC, at the Gastrointestinal Cancers Symposium, which is co-sponsored by the
American Society of Clinical Oncology and is being held in Hollywood, Florida
this week.
"The new targeted therapies for cancer, such as Tarceva, have great potential,
but the molecular diversity of tumors can limit responses to a small percentage
of patients," stated Dr. Oza. "I am excited to be involved with eTAG technology
as it may allow physicians to identify those patients who are more likely to
respond to specifically targeted therapies like Tarceva."
In this study, tumor and skin samples were collected from 18 metastatic
colorectal cancer patients being treated with a continuous oral dose of
erlotinib. Samples were taken prior to treatment and seven days later. Each
sample was tested with three different eTAG assays that measured the activity
of human epidermal growth factor receptor (EGFR), the molecular target of
erlotinib. Dysregulation, or malfunctioning, of EGF receptors is associated
with disease progression in cancer patients. eTAG assays performed on samples
after one week of treatment with erlotinib demonstrated that the presence of
EGFR dimers correlated with outcome in the seven patients who had stable
disease and were responding to the erlotinib. Eleven patients had progressive
disease, meaning they were non-responders to the treatment.
The researchers used three different methods to predict disease stability.
Assays that showed a reduction in Her1/Her1 receptor dimerization, or pairing,
coupled with assays that showed an increase in Her1/Her2 receptor dimerization,
correlated with stable disease with 100% sensitivity and 88.9% specificity.
Assays that showed a reduction in Her1 phosphorylation, or activation, in tumor
samples correlated with stable disease with 100% sensitivity and 88.9%
specificity. Assays that showed a reduction of Her1 phosphorylation in skin
samples predicted stable disease with 85.7% sensitivity and 100% specificity.
"We are very encouraged by the results of this pilot study, which reinforce the
potential of the eTAG System to provide truly personalized prognostic
information. These data mirror results from another recent study utilizing our
eTAG technology to predict treatment outcomes in patients with breast cancer,"
said Sharat Singh, Ph.D., ViroLogic's Chief Technical Officer, Oncology, and
co-author of the study. "Our eTAG assays showed excellent correlations with
treatment response in both studies. This may be an effective method of
predicting outcomes with targeted therapies, and we plan to conduct larger,
confirmatory studies."
About the eTAG System
ViroLogic's eTAG assays enable detailed analysis of protein drug targets and
signaling pathways in cancer cells, including samples that are formalin-fixed,
paraffin-embedded, which is the standard format in most pathology labs. The
assays can provide information on a drug's mechanism of action, selectivity and
potency in a biological setting in pre-clinical research, and enable enrichment
or selection of clinical trial populations later in a drug's development. In
addition, ViroLogic believes these assays will ultimately be used to help
physicians better determine whether certain therapies are more appropriate for
individual cancer patients, and whether to combine therapies with different
mechanisms or properties.
About ViroLogic
ViroLogic is a biotechnology company advancing individualized medicine by
discovering, developing and marketing innovative products to guide and improve
treatment of serious infectious diseases and cancer. The Company's products are
designed to help doctors optimize treatment regimens for their patients that
lead to better outcomes and reduced costs. The Company's technology is also
being used by numerous biopharmaceutical companies to develop new and improved
antiviral therapeutics and vaccines as well as targeted cancer therapeutics.
More information about the Company and its technology can be found on its web
site at http://www.virologic.com/.
FORWARD LOOKING STATEMENTS
Certain statements in this press release are forward-looking, including
statements relating to the ability of the eTag System to predict treatment
outcomes, drug potency or selectivity. These forward-looking statements are
subject to risks and uncertainties and other factors, which may cause actual
results to differ materially from the anticipated results or other expectations
expressed in such forward-looking statements. These risks and uncertainties
include, but are not limited to risks and uncertainties relating to the
performance of our products; anticipated progress in development and
commercialization of our eTag assay system; the potential for use of our eTag
assays in clinical development programs; the potential for use of our eTag
assays as diagnostic tests; our ability to successfully conduct clinical
studies and the results obtained from those studies; whether larger
confirmatory clinical studies will confirm the results of initial studies; our
ability to establish reliable, high-volume operations at commercially
reasonable costs; expected reliance on a few customers for the majority of our
revenues; actual market acceptance of and reimbursement for our products and
adoption of our technological approach and products by pharmaceutical and
biotechnology companies; competition from other companies and technologies; our
estimate of the size of our markets; our estimates of the levels of demand for
our products; our ability to develop sales, marketing and organizational
capabilities suitable for the further development and commercialization of our
eTag assays; the ultimate validity and enforceability of our patent
applications and patents; and the possible infringement of the intellectual
property of others. For a discussion of other factors that may cause our actual
events to differ from those projected, please refer to our most recent annual
report on Form 10-K and quarterly report on Form 10-Q, as well as other
subsequent filings with the Securities and Exchange Commission.
NOTE: eTag is a trademark of ViroLogic, Inc. Tarceva(R) is a registered
trademark of Genentech.
DATASOURCE: ViroLogic, Inc.
CONTACT: Alfred Merriweather, Vice President and CFO of ViroLogic,
+1-650-635 -1100; or Carolyn Bumgardner Wang of WeissComm Partners,
+1-415-692-4218, or , for ViroLogic
Web site: http://www.virologic.com/