ViroLogic and AstraZeneca to conduct Iressa biomarker study

ViroLogic announced today that it had entered into an agreement with AstraZeneca to conduct a cancer biomarker study with application to Iressa, AstraZeneca's selective epidermal growth factor receptor kinase inhibitor. ViroLogic, utilizing its proprietary eTag 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.