HER1 and HER3 VeraTag(TM) Assays are Now Available for Use in Development and Clinical Evaluation of Cancer Therapeutics
May 01 2008 - 5:11PM
PR Newswire (US)
Expanded Range of HER1, HER2 and HER3 Assays to Provide Unique
Insights and Facilitate Development of Personalized Cancer
Therapies SOUTH SAN FRANCISCO, May 1 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (NASDAQ:MGRM) today announced that the
company's HER1 and HER3 Quantitative Protein Assays are now
available for clinical development use. Built on Monogram's
VeraTag(TM) platform, the HER1 and HER3 assays provide unique,
quantitative measurements of protein expression and activity in
formalin fixed paraffin embedded (FFPE) tumor samples. These assays
supplement HERmark(TM), Monogram's HER2 and HER2:HER2 Homodimer
Breast Cancer Assay, and expands the potential clinical reach of
Monogram's VeraTag assays to lung, colorectal and other cancers.
"We are excited to make the HER1 and HER3 assays available for
clinical development use," said William Young, president and CEO of
Monogram Biosciences. "Our first VeraTag product, HERmark, is
already available for use in clinical development programs through
our CLIA-approved laboratory and provides quantitative and accurate
measurements of the expression of HER2 and HER2:HER2 homodimers.
The addition of the HER1 and HER3 assays expands the reach of our
VeraTag technology and we look forward to forging collaborations
with biopharmaceutical companies to advance the use of our
diagnostics and enable the development of new treatment options for
those living with cancer." "Oncologists have long known about the
role that HER2 plays in breast cancer and, although far from
perfect, have had some tools available to measure it," said Michael
Bates, M.D., Monogram vice president of clinical research.
"Accurate, quantitative measurements for EGFR (HER1) and HER3 have
never before been available and are badly needed to help unravel
the complex biology of cancer and enable the development and
clinical use of targeted cancer therapies." "Our HER1 and HER3
assays provide accurate, precise and highly reproducible
measurements of these key analytes with sensitivity more than five
times that of routinely performed IHC testing," said Gordon Parry,
Ph.D., Monogram vice president of research & development,
oncology. "Making these measurements in FFPE tissue is particularly
important as this is the standard fixation and storage method in
most pathology laboratories." Monogram has a growing portfolio of
VeraTag assays that measure proteins, protein complexes and
post-translational modifications such as phosphorylation, in FFPE
tumor samples and can aide cancer drug development and clinical
evaluation. The HERmark Assay is validated according to CAP/CLIA
regulations for routine testing in our CLIA-approved clinical
reference laboratory and provides measurements of HER2 and
HER2:HER2 homodimers. In addition to the HER1 and HER3 assays that
are now available for clinical development use, Monogram has assays
in advanced development for the measurement of heterodimers of HER1
and HER2 (HER1:HER2), for the measurement of heterodimers of HER2
and HER3 (HER2:HER3), and for the measurement of a truncated form
of HER2, known as p95. These activated proteins are believed to
mediate resistance to Herceptin(R) in patients with breast cancer
and are targets of other cancer drugs in development. This extended
range of assays will expand the clinical reach of Monogram's assays
to lung, colorectal and other cancers. Understanding these protein
markers is expected to inform the rational design of combination
therapies, such as those for patients with resistance to Herceptin.
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. These
forward-looking statements include references to, the ability of
VeraTag technology to significantly improve the information
available to physicians, results of studies intended to demonstrate
clinical utility of our VeraTag technology and products and
anticipated clinical and laboratory validation of VeraTag in a CLIA
setting, future commercialization of the HERmark assay based on the
VeraTag technology, expected protection provided by patents, and
possible regulation of our products by the FDA. 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; the
growth in revenues; the risk that our VeraTag assays 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, 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 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; 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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