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Monogram announces availability of HERmark and HER1 and HER3 Total Protein Assays in Collaborative Biomarker Study.

Monogram Biosciences, Inc. (S. San Francisco, CA) announced that scientific collaborators have presented additional clinical results on HERmark, the company's novel oncology assay, as a means to measure HER2 total protein and homodimer levels and predict response to Herceptin (trastuzumab) in patients with metastatic breast cancer at the 44th ASCO Annual Meeting taking place in Chicago, Illinois. Monogram also announced the initiation of a Collaborative Biomarker Study involving the company's HERmark Breast Cancer Assay and the HER1 and HER3 Total Protein Assays.

"HERmark is the first diagnostic built upon our VeraTag technology," said Monogram CEO Bill Young. "We are announcing two developments that will elevate the profile of HERmark in the oncology community. First, important clinical data presented demonstrates the superiority of HERmark over FISH testing for HER2. Second, we are initiating a study that will provide an opportunity for participating oncologists to experience first hand the superiority of HERmark in their clinical practices. We look forward to completing our commercial planning and to a future commercial launch of HERmark throughout the United States"

The oral presentation, entitled "Total HER2 and HER2 Homodimer Levels Predict Response to trastuzumab," discussed 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 study was conducted by Allan Lipton, M.D. and colleagues at the Experimental Oncology Research Lab at Penn State/Hershey Medical Center.

"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. "The data show that higher HER2 total protein and HER2 homodimer levels, as measured by HERmark, predict which patients have the best chance of responding to Herceptin, even within a population that has already been determined to be FISH+ on central laboratory testing."

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, with most having been selected by IHC performed in a central laboratory. Subsequently, all patient samples were retested using FISH performed at a central laboratory. Using HERmark to measure HER2 total protein and HER2 homodimer levels, the results were compared with the patients' response to treatment with Herceptin.

Monogram also announced that it has initiated a Collaborative Biomarker Study using its VeraTag technology platform. The retrospective study is designed to compare conventional IHC and FISH methods of HER2 testing with the quantitative measurements of HER2 total protein and HER2 homodimers provided by Monogram's HERmark Breast Cancer Assay. Additionally, the study aims to describe the expression/co-expression profiles identified by Monogram's HER1 and HER3 Total Protein Assays along with HER2 total protein and homodimer levels identified by HERmark to facilitate analyses of how such measurements may correlate with certain laboratory and clinical parameters, including disease progression.

Initially, the study will be conducted as a pilot program in up to fifteen sites. Breast cancer patients will already have been selected for treatment with conventional HER2 tests and outcomes will subsequently be compared to both the conventional and VeraTag measurements.

"HERmark represents a major step forward in the assessment of HER2 expression and has the potential to facilitate significantly more accurate selection of therapies for breast cancer patients," said Young. "We expect that this Collaborative Biomarker Study will add to the body of data describing HER2 total protein and HER2 homodimer expression and their relationship to clinical outcomes. Assessing the quantitative levels of expression and co-expression of HER1 and HER3 proteins in conjunction with HER2 measurements by HERmark will substantially increase our knowledge of how the expression of these HER-family proteins are represented in breast cancer."

HERmark is a proprietary diagnostic that accurately quantifies HER2 total protein expression and HER2 homodimerization 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. Assays based on the VeraTag technology platform are 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.

Monogram Biosciences, Inc.

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Publication:BIOTECH Patent News
Date:May 1, 2008
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