SOUTH SAN FRANCISCO, Calif., Dec. 1 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc., formerly ViroLogic, Inc., announced the publication in the British Journal of Cancer, a Nature Publishing Group journal, of a study demonstrating the potential of the company’s eTag(TM) technology to assess the activation of specific signal transduction pathways in patient samples. The paper reports a study of correlations between skin toxicity, a common side effect of certain targeted cancer therapies but not others, and the dimerization status of EGFR and HER2 proteins present in skin. The study, presented by researchers from the Cedars-Sinai Medical Center, illustrates how the eTag technology’s ability to identify and quantitate EGFR dimerization can be used to understand drug effects.
“Monogram’s eTag technology is able to identify protein dimerization status in clinical tissue,” said co-author David Agus, MD, Research Director at the Louis Warschaw Prostate Cancer Center at Cedars-Sinai Medical Center and senior author of the study. “The eTag assay is both highly sensitive and quantitative, and these attributes make it a very promising clinical tool for identifying critical protein markers that may be indicative of patient response to therapies.”
The study showed that EGFR homodimers are the predominant form of dimer present in normal keratinocytes, and that inhibition of EGFR homodimerization by certain drugs that target EGFR correlates with skin toxicity, whereas drugs that target HER2 may not lead to similar skin toxicity because EGFR/HER2 heterodimers are absent in normal skin. This provides a plausible explanation for the observation that skin toxicity is associated with drugs that target EGFR but not with those that target HER2.
“For Monogram, this study is important because it represents an important step in establishing scientific validation of our eTag technology in a peer- reviewed setting,” said Michael Bates, MD, Monogram’s Vice President of Clinical Research. “Additional studies are underway with a number of collaborators to demonstrate the ability of eTag assays to predict responsiveness of individual patients to certain targeted cancer therapies.”
About the eTag System
Monogram’s eTag assays enable detailed analysis of protein drug targets and signaling pathways in cancer cells, using tissue lysates or FFPE specimens, 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 selection of clinical trial populations later in a drug’s development. In addition, Monogram believes these assays may 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. The first commercially available activated receptor test panel based on eTag technology, focused on the EGFR/HER receptor family, is planned to be introduced in 2006.
About Monogram Biosciences, Inc.
Monogram, formerly ViroLogic, Inc., is 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.monogrambio.com.
eTag(TM) is a trademark of Monogram Biosciences, Inc.
FORWARD LOOKING STATEMENTS
Certain statements in this press release are forward-looking, including statements regarding the ability of assays based on the eTag technology to predict individual patient response to targeted cancer therapies. 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; whether measurement of dimerization or protein pathway activation are key indicators in determining individual patient response; 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; whether the results of studies conducted with patient samples treated with a particular targeted cancer therapy will be representative of results with other targeted therapies; whether clinical data derived from these studies will be adequate to support the commercial introduction of a test for patient responsiveness to targeted cancer therapies; the timing and launch of eTag assays for patient use; our ability to establish reliable, high-volume operations at commercially reasonable costs; the development of competitive technologies; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the timing and ultimate size of pharmaceutical company clinical trials; whether payors will authorize reimbursement for its products; whether the FDA or any other agency will decide to regulate Monogram’s products or services; whether the Company will encounter problems or delays in automating its processes; whether licenses to third party technology will be available; whether Monogram is able to build brand loyalty and expand revenues; the potential impact of cash and or stock payments by us on the Contingent Value Rights issued to shareholders of ACLARA; and whether Monogram will be able to raise sufficient capital when required. For a discussion of other factors that may cause Monogram’s actual events to differ from those projected, please refer to the Company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.
Contacts: Alfred G. Merriweather Jeremiah Hall Chief Financial Officer Feinstein Kean Healthcare Tel: 650 624-4576 Tel: 415 677-2700 amerriweather@monogrambio.comjeremiah.hall@fkhealth.com
Monogram Biosciences, Inc.
CONTACT: Alfred G. Merriweather, Chief Financial Officer of MonogramBiosciences, Inc., +1-650-624-4576, amerriweather@monogrambio.com; orJeremiah Hall of Feinstein Kean Healthcare for Monogram Biosciences, Inc.,+1-415 677-2700, jeremiah.hall@fkhealth.com
Web site: http://www.monogrambio.com/
