ViroLogic and AstraZeneca to Conduct Iressa(R) Biomarker Study
Main Category: Lung CancerArticle Date: 08 Mar 2005 - 0:00 PDT
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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."
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 http://www.virologic.com.
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. http://www.virologic.com
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Iressa Biomarker Studies
posted by Gregory D. Pawelski on 9 Apr 2007 at 5:07 pmA genomic test can help to find out if a cancer patient will benefit from chemotherapy or not, and if they do, cell function analysis can help see what treatments have the best opportunity of being successful. Other tests, such as those which identify DNA, or RNA sequences or expression of individual proteins often examine only one component of a much larger, interactive process. And one gets more accurate information when using intact RNA isolated from "fresh" tissue than from using degraded RNA, which is present in paraffin-fixed tissues.
Whole Cell Profiling (via Cell Function Analysis) measures the response of the tumor cells to drug exposure. Following this exposure, they measure both cell metabolism and cell morphology. The integrated effect of the drugs on the whole cell, resulting in a cellular response to the drug, measuring the interaction of the entire genome. No matter which genes are being affected, Whole Cell Profiling is measuring them through the surrogate of measuring if the cell is alive or dead.
For example, the epidermal growth factor receptor (EGFR) is a protein on the surface of a cell. EGFR inhibiting drugs certainly do target specific genes, but even knowing what genes the drugs target doesn't tell you the whole story. Both Iressa and Tarceva target EGFR protein-tyrosine kinases. But all the EGFR mutation or amplificaton studies can tell us is whether or not the cells are potentially susceptible to this mechanism of attack.
It doesn't tell you if Iressa is better or worse than Tarceva or other drugs which may target this. There are differences. The drugs have to get inside the cells in order to target anything. So, in different tumors, either Iressa or Tarceva might get in better or worse than the other. And the drugs may also be inactivated at different rates, also contributing to sensitivity versus resistance.
One of the most promising new approaches that may deal with early detection of cancer is called Proteomics (Protein Expression Analysis), the study of proteins in the cells, tissues and body fluids. Even before a tumor can be felt, some researchers have found, the tumor begins secreting a distinctive pattern, or fingerprint of proteins. Here, you go beyond genes (DNA, the Genomic Analysis or structure of the human genome) and beyond Gene Expression (the measure of RNA content, like Her2/neu in breast cancer) to measure the actual proteins themselves.
Genomic Analysis is only important insofar as it influences Gene Expression Analysis, which is only important insofar as it influences Protein Expression Analysis (Proteonomics), which is only important insofar as it influences Protein Function Analysis (are proteins active or inactive), which is only important insofar as it influences Cell Function Analysis (cell culture testing), which is only important insofar as it influences Disease Analysis (doing something to treat the patient and then making a measurement on the patient with CT/PET scanning), in that order. There is an inverse hierachy between relevance and ease of measurement.
There are many pathways to altered cellular (forest) function (hence all the different "trees" which correlate in different situations). It serves to validate Whole Cell Profiling. The forest is looked at, and not the trees. Whole Cell Profiling measures what happens at the end (the effects on the forest), rather than the status of the individual trees. Cancer is a complex disease and needs to be attacked on many fronts. The best thing to do is to combine these different tests in ways which make the most sense. The future of cancer therapy will be personalized treatments for individual patients, and will require a combination of novel diagnostics and therapeutics.
Improving cancer patient diagnosis and treatment through a combination of cellular and gene-based testing will offer predictive insight into the nature of an individual's particular cancer and enable oncologists to prescribe treatment more in keeping with the heterogeneity of the disease. The biologies are very different and the response to given drugs is very different.
Source: Cell Function Analysis
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