Investigator to discuss assay built on VeraTag(TM) technology's ability to
predict response to Herceptin(R)
SOUTH SAN FRANCISCO, Calif., May 16 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that scientific collaborators will present results on HERmark(TM), the company's novel oncology assay, as a means to measure HER2 and predict response to Herceptin(R) (trastuzumab) in patients with metastatic breast cancer at the upcoming 44th ASCO Annual Meeting taking place in Chicago, Illinois.
The oral presentation, entitled "Total HER2 and HER2 Homodimer Levels Predict Response to trastuzumab", which will take place on Monday, June 2, 2008 from 1:15PM - 2:45PM, will discuss the findings of a study that investigated the HERmark assay's ability to identify and discriminate among patients with metastatic breast cancer who experienced different degrees of response to trastuzumab. The results of the study, by Allan Lipton, M.D. and colleagues at the Experimental Oncology Research Lab at Penn State/Hershey Medical Center will be presented by Kim Leitzel, M.Sc., Senior Research Associate in Dr. Lipton's laboratory.
"Current testing methods for determination of the likelihood of benefit from Herceptin are not adequate," said Allan Lipton M.D., Professor of Medicine & Oncology at Hershey Medical Center/Penn State University. "HERmark represents a promising new technology that could provide enhanced information on which patient therapy decisions may be based."
"HERmark is the first diagnostic built upon our VeraTag technology," said Monogram CEO Bill Young. "We believe HERmark represents an advance in the field by providing very reproducible quantitative measures of HER2 protein expression levels and, for the first time, measurements of HER2 homodimers. We believe these measurements will make the selection of patients for Herceptin therapy more precise, as well as provide quantitative tools for the ongoing investigation of HER2 biology in clinical specimens."
The study used Monogram's proprietary HERmark assay to analyze tissue samples from patients with metastatic breast cancer who were treated with Herceptin. Patients had been previously selected for Herceptin therapy by IHC or FISH testing. Using HERmark to measure total HER2 and HER2 homodimer levels, the results were compared with the patients' response to treatment with Herceptin.
While current testing methods identified all these patients as being equally likely to respond to Herceptin treatment, Monogram's HERmark assay was able to distinguish separate sub-groups of patients with different clinical outcomes, and those outcomes correlated with the quantitative measurements of HER2 status provided by HERmark.
Patients with higher levels of HER2 and HER2 homodimers correlated with a higher probability of objective response (an endpoint in tumor evaluation) to Herceptin therapy. In addition, those patients with higher HER2 expression levels had a median time to progression of 11.6 months while those in the lower half of the distribution had a median time to progression of 5.4 months. This was also true of patients with higher levels of HER2 homodimers who had a median time to progression of 11.6 months compared to those with lower HER2 levels who had a median time to progression of 5.8 months. Further analysis revealed that there was a trend in favor of higher HER2 expression and longer overall survival (median survival 37.4 months vs. 28.7 months) although this was not statistically significant (p=0.2). Finally, Cox multivariate analyses identified HER2 expression and HER2 homodimer levels as independent correlates of both time to progression and overall survival.
HERmark is a proprietary diagnostic that accurately quantifies HER2 expression and dimerization in patients with breast cancer. Preliminary data from three cohorts of Herceptin-treated patients with metastatic breast cancer who were identified as "HER2 positive" by conventional assays suggest that HERmark can identify patients who are likely to respond to Herceptin with greater precision than currently available tests, permitting stratification of patients according to their degree of clinical benefit from the drug. Additional studies of HERmark for breast cancer in both the metastatic and adjuvant settings are in progress.
VeraTag is a proximity-based assay technology platform that accurately quantifies proteins and functional protein complexes. This platform provides a researcher or clinician a more thorough understanding of protein-protein interactions or signaling pathway activity allowing for disease characterization at the molecular level. VeraTag is designed to run on standard formalin-fixed paraffin embedded (FFPE) patient samples.
Monogram 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 anti-viral 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.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to, the ability of VeraTag technology and the HERmark assay to predict response to Herceptin or to significantly improve the information available to physicians, results of studies intended to demonstrate clinical utility of HERmark, and potential commercialization of the HERmark assay. 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, including HERmark; the growth in revenues; the risk that our VeraTag assays, including HERmark may not predict response to Herceptin or other therapeutic agents; the risk that we may not be able to obtain additional cohorts of patient samples for additional VeraTag studies, 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; actual market acceptance of our products for patient use 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 impact of competition; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our 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.
VeraTag and HERmark are trademarks of Monogram Biosciences, Inc.
Herceptin is a registered trademark of Genentech, Inc.
Contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624-4576 Tel: 415 677-2700
|SOURCE Monogram Biosciences, Inc.|
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