ViroLogic, Inc (Nasdaq: VLGC) announced today that it had entered into an agreement with
AstraZeneca (NYSE: AZN) to conduct a cancer biomarker study with application
to Iressa(R), AstraZeneca's selective epidermal growth factor receptor kinase
inhibitor. ViroLogic, utilizing its proprietary eTag(TM) assays will test
tumor samples from lung cancer patients treated with Iressa to evaluate the
utility of these assays in targeting patients who would most likely benefit
from Iressa.
Under the agreement, AstraZeneca will provide greater than 100 tumor
samples from a Phase IV trial of Iressa in the standard pathology lab format,
formalin-fixed, paraffin-embedded (FFPE) thin sections on glass slides.
ViroLogic will test the samples with its eTag assays for specific protein
biomarkers that ViroLogic has identified that are indicative of activated
signalling pathways in cells, which can drive the accelerated growth of cancer
cells. AstraZeneca will make payments to ViroLogic for the project. Other
financial details were not disclosed.
In recent months there have been several reports that mutations in the
epidermal growth factor receptor (EGFR) gene, which codes for the protein
targeted by Iressa in cancer cells, as well as other genes, can indicate which
patients will respond to the drug. However, it appears that more patients
respond to Iressa than have these mutations, and researchers believe that
other cellular processes are responsible for this discrepancy. The ViroLogic
eTag assays look at cancer cells at a higher level than the gene, focusing on
functional proteins, which in many cases are the actual targets for drugs.
Being more proximal to the disease process and the drug's modulation of it,
assays for these proteins could provide a more accurate prediction of a
patient's likely response to a particular drug.
"We are impressed by ViroLogic's technology, and think it may provide new
insights into complex biology," said Alan Barge, MD, Vice President, Clinical
Oncology at AstraZeneca. "We hope that the new information we obtain at the
cellular level with the eTag assays will have relevance clinically, to better
identify specific, individual patients who are likely to respond to Iressa.
We eagerly await the results of this study, and to evaluating whether we will
be using these types of assays more broadly in our clinical efforts in
oncology."
"We are pleased to be working with AstraZeneca," said William D. Young,
ViroLogic's Chairman and CEO. "They are a leader in the development of novel
oncology therapies, and we believe that our assays can enhance those therapies
by offering valuable information to physicians prescribing Iressa, and to the
clinical researchers developing these agents. We believe our assays could
impact other drugs in AstraZeneca's oncology pipeline as well."
ViroLogic's eTag assays enable the analysis of an individual patient's
tumor sample at the protein and signaling pathway level, and provide a
different, and possibly more immediate and relevant view of the cancer process
in that patient than do certain genetic analyses because drugs typically act
on proteins. Testing for activated protein pathways in FFPE samples is a
unique advantage of eTag assays. ViroLogic believes the future of cancer
therapy will be personalized treatments for individual patients, and that this
will require a combination of novel diagnostics and therapeutics.
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 biotechnology and pharmaceutical 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 virologic.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the
world's leading pharmaceutical companies with healthcare sales of over
$21.4 billion and leading positions in sales of gastrointestinal,
cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca
is listed in the Dow Jones Sustainability Index (Global) as well as the
FTSE4Good Index.
Forward-Looking Statements
Certain statements in this press release are forward-looking, including
statements relating to the ability of the eTag technology 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.
Trademarks
eTag is a trademark of ViroLogic, Inc. Iressa is a registered trademark
of AstraZeneca.
ViroLogic, Inc.
virologic
View drug information on Iressa.