Monogram Announces Presentation of Clinical Data for the HERmark(TM) Breast Cancer Assay at the 44th ASCO Annual Meeting
June 02 2008 - 3:45PM
PR Newswire (US)
Monogram announces availability of HERmark and HER1 and HER3 Total
Protein Assays in Collaborative Biomarker Study SOUTH SAN
FRANCISCO, Calif., June 2 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc. (NASDAQ:MGRM) today announced that scientific
collaborators have presented additional clinical results on
HERmark(TM), the company's novel oncology assay, as a means to
measure HER2 total protein and homodimer levels and predict
response to Herceptin(R) (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. "Today we are announcing
two developments that will elevate the profile of HERmark in the
oncology community. First, important clinical data presented today
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 U.S." HERmark Clinical Data 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 presented today
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. In Cox multivariate analyses
including the variables IHC, FISH, and HER2 total or HER2
homodimers, the HERmark measurements outperformed both IHC and
FISH, and were identified as independent correlates of both time to
progression (TTP) and overall survival (OS). -- For TTP: HER2 total
protein and HER2 homodimers had hazard ratios of 0.39 (p=0.018) and
0.53 (p=0.092), respectively, while FISH showed hazard ratios of
1.1 (p=0.8) and 0.92 (p=0.8), respectively. -- For OS: HER2 total
protein and HER2 homodimers had hazard ratios of 0.4 (p=0.058) and
0.35 (p=0.026), respectively, while FISH showed hazard ratios of
1.4 (p=0.57) and 1.6 (p=0.36), respectively. Even within the
subgroup of patients (74 of 103) that were confirmed HER2-positive
by centrally performed FISH, Monogram's HERmark assay was shown in
multivariate models to be a statistically significant predictor of
time to progression and overall survival following Herceptin
treatment. -- For TTP: HER2 total protein and HER2 homodimers
showed hazard ratios of 0.3 (p=0.002) and 0.53 (p=0.094),
respectively. -- For OS: HER2 total protein and HER2 homodimers
showed hazard ratios of 0.25 (p=0.006) and 0.31 (p=0.017),
respectively. Collaborative Biomarker Study Monogram also announced
today 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." About HERmark 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. About VeraTag 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. About
Monogram 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 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 the potential commercialization of
the HERmark assay or other assays based on the VeraTag technology
platform. 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, including the Collaborative Biomarker Study, 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 amerriweather@ jeremiah.hall@ monogrambio.com fkhealth.com
DATASOURCE: Monogram Biosciences, Inc. CONTACT: Alfred G.
Merriweather, Chief Financial Officer of Monogram Biosciences,
Inc., +1-650-624-4576, ; or Jeremiah Hall of Feinstein Kean
Healthcare for Monogram Biosciences, Inc., +1-415-677-2700, Web
site: http://www.monogrambio.com/
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