HER2 Homodimer and HER2 Total Protein Assays Validated in CLIA Laboratory
SOUTH SAN FRANCISCO, Dec. 14 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc. (Nasdaq: MGRM) today presented the results of a study
detailing the HERmark(TM) Assay's ability to identify metastatic breast
cancer patients who are most likely to respond to Herceptin(R). The study
results were presented this week at the San Antonio Breast Cancer
Symposium. Also this week, Monogram received confirmation from the College
of Pathologists (CAP) that the HERmark assays are approved for routine
patient testing in Monogram's CLIA certified clinical reference laboratory.
"The results presented today are an important step along the way to
clinical validation of HERmark, the first product based on the VeraTag
technology platform," said William Young, Monogram chief executive officer.
"In addition to the presentation of important clinical data, I am pleased
to report today that the HERmark assays have completed their validation
process in Monogram's CLIA-certified clinical reference laboratory. The
establishment of solid technical validation data and the ability to perform
the assays under high-throughput, well controlled conditions will provide a
strong basis for commercialization of HERmark after completion of our
ongoing clinical studies."
In the study reported today, Monogram analyzed tissue samples from
patients with metastatic breast cancer who were treated with Herceptin,
having been selected for such treatment by centralized IHC testing. While
current testing methods identified all these patients as being appropriate
for Herceptin treatment, Monogram's HERmark Assay was able to distinguish
separate sub-populations of patients with different clinical outcomes.
Study details: Those patients with higher HER2 expression levels (i.e.
in the upper half of the distribution for the study cohort) experienced a
59% objective response rate while those with lower levels of HER2
expression (i.e. in the lower half of the distribution) had a response rate
of only 18%. Additional analyses revealed that patients with higher HER2
expression values had a median time-to-progression of 12.8 months while
those in the lower half of the distribution had a median
time-to-progression of only 4 months. This result was statistically
significant (p = 0.01). Finally, multivariate Cox proportional hazards
models identified HER2 expression (HR = 0.16, p < 0.001) and HER2:HER2
dimer levels (HR = 0.32, p < 0.001) as measured by HERmark as being
statistically significant predictors of time-to-progression.
"Current testing technologies do not provide an accurate or precise
view of HER2 biology in breast cancer, classifying patients as either HER2
'positive' or HER2 'negative'," continued Young. "At best, conventional
technologies provide a semi-quantitative analysis. However, only about half
of metastatic patients selected by current technologies for Herceptin
treatment respond to the drug. Data are now emerging to suggest that
patients who could benefit from Herceptin may be missed by currently used
assays. Our HERmark studies have provided data which consistently indicate
that HERmark can precisely measure HER2 expression and HER2:HER2 dimer
levels in clinical FFPE samples, and that those patients with higher levels
of expression have significantly better clinical outcomes than those with
lower levels. These data strongly suggest that HERmark can identify
patients who are likely to respond to Herceptin better than the assays
currently in use."
HERmark Assay in Metastatic Breast Cancer
At ASCO in June 2007, Monogram reported results of studies of HERmark
in two patient cohorts. In the first of these studies, it was demonstrated
that within a population of patients that were stringently selected by FISH
testing, the HERmark assay was able to measure a gradient of HER2
expression and HER2 homodimer levels that was significantly correlated with
time-to- progression and overall survival on Herceptin. In the second
metastatic patient cohort presented at ASCO, selected by IHC in a
clinic-based setting, the HERmark assay was also able to demonstrate that
patients who were confirmed HER2 positive by IHC on repeat testing showed a
gradient of response, and that those with higher levels of HER2 expression
and HER2 homodimer levels as measured by HERmark lived longer than those
who had lower levels. The results of these two previously reported cohorts,
along with the third cohort presented today, provide the basis for
Monogram's ongoing work in metastatic breast cancer. There are
approximately 60,000 women annually in the U.S. who are newly diagnosed
with Stage IV breast cancer or who have progressed from earlier stages of
disease. These are patients for whom the cancer has spread beyond the
breast, and in many cases multiple treatments may have already been
provided.
HERmark Assay in the Adjuvant Setting
Monogram has initiated a study with one of the leading oncology
clinical trial cooperative groups in the country. In this ongoing study, we
are performing HERmark assays on tissue samples from up to 1,600 breast
cancer patients treated with Herceptin in the adjuvant setting. The goal of
the study is to clinically validate the ability of HERmark to predict
clinical outcome in these Herceptin-treated patients. These patients are
generally newly diagnosed with breast cancer, have had surgery and are now
on a first course of treatment to supplement the surgical procedure. In the
U.S., there are approximately 200,000 new cases of breast cancer each year,
most of whom are candidates for adjuvant treatment and therefore would be
candidates for the HERmark adjuvant breast cancer assay.
About HERmark
HERmark is a proprietary diagnostic that accurately quantifies HER2
expression and 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
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, for
Monogram Biosciences, Inc.
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