SOUTH SAN FRANCISCO, Calif., Sept. 23 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (Nasdaq: MGRM) announced today that it has
initiated a study, in collaboration with the Dana-Farber Cancer Institute
(DFCI), to evaluate Monogram's HERmark(TM) Breast Cancer Assay in
metastatic breast cancer.
In the study, Monogram's proprietary HERmark assay will be used to
analyze approximately 600 tissue samples from patients with breast cancer,
approximately half of whom were eligible for treatment with Herceptin(R) on
the basis of prior HER2 IHC and/or FISH testing. HERmark measurements of
HER2 total protein and HER2 homodimer levels will be compared with the
results of IHC and/or FISH testing as well as response to treatment with
Herceptin.
"Results from prior studies in metastatic breast cancer have suggested
that HERmark can identify subsets of patients with different responses to
Herceptin even though they had all been previously assessed as
'HER2-positive' by IHC and/or FISH, tested centrally," said Michael Bates,
M.D., Monogram's Vice President of Clinical Research. "The aim of this
study is to test the hypothesis that HERmark selects patients for Herceptin
treatment in the metastatic setting better than other currently available
assays, as well as to test cutoff values that have been previously defined
for HERmark. In addition, we will also measure HER3 expression levels in
these tumors and see if they correlate with clinical outcomes in this
cohort. The study will also provide enough tissue to facilitate testing of
assays that are in advanced development at Monogram, including assays for
HER1 expression, p95 expression, as well as heterodimers of HER2, such as
HER2:HER3 and HER1:HER2."
"The VeraTag technology represents a novel approach to the study of
HER2- positive breast cancer by virtue of its ability to make accurate
measurements of HER2 and its homodimer in actual breast tumors," said Ian
Krop, M.D., Ph.D., Assistant Professor of Medicine, Division of Medical
Oncology at the Dana Farber Cancer Institute and principal investigator of
the study. "We look forward to working with Monogram on this study to try
to develop a better understanding of the biology of HER2 positive breast
cancer and the biomarkers that influence its clinical outcome."
About HERmark
HERmark is a proprietary diagnostic that accurately quantifies HER2
total protein levels and HER2 homodimerization in patients with breast
cancer. HERmark is a CLIA-validated assay that is performed exclusively in
Monogram's CAP-certified clinical reference laboratory in South San
Francisco. Robust, accurate, sensitive and reproducible measurements of
HER2 status are reported to physicians with a turnaround time of 7 days.
With the accurate measurements provided by HERmark, it is expected that
as many as 15-20% of patients determined by conventional technologies to be
HER2- negative would be reclassified by HERmark.
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.
About Dana-Farber Cancer Institute
Dana-Farber Cancer Institute is a principal teaching affiliate of the
Harvard Medical School and is among the leading cancer research and care
centers in the United States. It is a founding member of the Dana-
Farber/Harvard Cancer Center (DF/HCC), a designated comprehensive cancer
center by the National Cancer Institute.
Forward-Looking Statements
Certain statements in this press release are forward-looking. These
forward-looking statements include references to the ability of 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 or other VeraTag assays. 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 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 HERmark or
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
Chief Financial Officer
Tel: 650 624 4576
amerriweather@monogrambio.com
Jeremiah Hall
Feinstein Kean Healthcare
Tel: 415 677-2700
jeremiah.hall@fkhealth.com
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer, +1-650-624-4576, amerriweather@monogrambio.com; or
Jeremiah Hall of Feinstein Kean Healthcare, +1-415-677-2700,
jeremiah.hall@fkhealth.com
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