Presentations highlight development of protein-based assays for HER1,
HER1:HER1 homodimers, HER3 and activated HER1:HER2 heterodimers
SOUTH SAN FRANCISCO, Oct. 22 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc. (Nasdaq: MGRM) today announced that Monogram scientists
have made presentations related to its expanding set of VeraTag assays at
the 20th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics in Geneva, Switzerland.
The first presentation, entitled "Development of proximity-based
immunoassays for activated HER1, HER2, and HER1:2 heterodimers in
formalin-fixed, paraffin-embedded cells", outlines the development of
sensitive and specific assays in fixed tumor cell lines. The second
presentation, entitled "Development of highly quantitative, sensitive and
reproducible assays for the detection of HER1 and HER3 in formalin-fixed,
paraffin-embedded tumor tissue", describes the validation of these assays
as providing quantitative and accurate measurements in human tumor tissue.
"EGFR/HER receptors are known to be significant to the proliferation of
many different cancers," said William Young, Monogram chief executive
officer. "HERmark(TM), our recently launched breast cancer assay, is
bringing new options to breast cancer patients with quantitative
measurements of HER2 total protein and HER2:HER2 homodimer. This week's
presentations in Geneva evidence Monogram's expanding portfolio of assays
and the growing reach of the VeraTag(TM) technology."
"With our VeraTag platform, we can make precise and quantitative
measurements of protein complexes that have not previously been possible,"
said Gordon Parry, Ph.D., Monogram vice president of research &
development, oncology. "The data presented this week, on the HER1 and HER3
total protein assays, the HER1:HER1 homodimer assay and the activated
HER1:HER2 heterodimer assay, provide support for the use of these assays in
drug development programs not only in breast cancer, our current focus, but
also in other cancer types."
In addition to the assays featured in this week's presentations,
Monogram has assays in advanced development for quantifying HER2:HER3
heterodimers, HER3:PI3K complex, a key downstream signaling complex in the
Akt pathway, and p95, a truncated form of HER2, for use in formalin-fixed,
paraffin embedded tumors. Measurements of these proteins or protein
complexes in a patient's tumor may provide valuable information on the key
signaling pathways driving tumor growth as well as potential mechanisms of
drug resistance. "This information is expected to inform the rational
design of combination therapies in a very wide range of cancers," added
Parry. "In breast cancer for example, expression of certain of these
protein markers may predict resistance to Herceptin(R) and indicate the
potential need for additional drugs that act by different mechanisms in
these patients."
Several additional presentations related to Monogram's VeraTag assays
will be made in 2008. Data on the HER2:HER3 heterodimer assay and the
HER3:PI3K complex assay will be presented at the AACR "Targeting the
PI3-Kinase Pathway in Cancer" meeting in Cambridge, MA in November.
Clinical data on HERmark, Monogram's commercially available HER2 and
HER2:HER2 homodimer assay, will be presented at the Chemotherapy Foundation
Symposium in New York in November and at the San Antonio Breast Cancer
Symposium in December.
About HERmark
HERmark is a proprietary diagnostic that accurately quantifies HER2
expression and HER2:HER2 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.
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. VeraTag is 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, including
statements regarding the demand for and performance of our products,
including our HERmark and VeraTag assays, the potential for enhancements to
our HERmark assay, the development of additional assays based on the
VeraTag platform, the results and timing of clinical studies on our
products and the presentation or publication of data from such studies.
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 and acceptance of our
products; the risk that our VeraTag assays, including HERmark, may not
predict response to particular therapeutic agents; the risk that we may not
be able to obtain additional cohorts of patient samples for additional
VeraTag studies, the risk that our VeraTag technology may not accurately
measure other proteins or protein complexes, 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; expected reliance on a few customers for
the majority of our revenues; 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 impact of
competition; the timing and ultimate size of pharmaceutical company
clinical trials; 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, including HERmark; whether the draft
guidance on Multivariate Index Assays issued by the 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, G.E. and other debt
agreements; potential Nasdaq proceedings to delist our common stock, our
ability to regain compliance with Nasdaq listing requirements, the impact
of a possible reverse split of the shares of our common stock, 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
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer of Monogram Biosciences, Inc., +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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