Investigator to discuss assay built on VeraTag(TM) technology's ability to
predict response to Herceptin(R)
SOUTH SAN FRANCISCO, Calif., May 16 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc. (Nasdaq: MGRM) today announced that scientific
collaborators will present results on HERmark(TM), the company's novel
oncology assay, as a means to measure HER2 and predict response to
Herceptin(R) (trastuzumab) in patients with metastatic breast cancer at the
upcoming 44th ASCO Annual Meeting taking place in Chicago, Illinois.
The oral presentation, entitled "Total HER2 and HER2 Homodimer Levels
Predict Response to trastuzumab", which will take place on Monday, June 2,
2008 from 1:15PM - 2:45PM, will discuss 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 results of the study, by Allan Lipton, M.D.
and colleagues at the Experimental Oncology Research Lab at Penn
State/Hershey Medical Center will be presented by Kim Leitzel, M.Sc.,
Senior Research Associate in Dr. Lipton's laboratory.
"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.
"HERmark represents a promising new technology that could provide enhanced
information on which patient therapy decisions may be based."
"HERmark is the first diagnostic built upon our VeraTag technology,"
said Monogram CEO Bill Young. "We believe HERmark represents an advance in
the field by providing very reproducible quantitative measures of HER2
protein expression levels and, for the first time, measurements of HER2
homodimers. We believe these measurements will make the selection of
patients for Herceptin therapy more precise, as well as provide
quantitative tools for the ongoing investigation of HER2 biology in
clinical specimens."
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. Using HERmark to measure total HER2 and HER2 homodimer
levels, the results were compared with the patients' response to treatment
with Herceptin.
While current testing methods identified all these patients as being
equally likely to respond to Herceptin treatment, Monogram's HERmark assay
was able to distinguish separate sub-groups of patients with different
clinical outcomes, and those outcomes correlated with the quantitative
measurements of HER2 status provided by HERmark.
Patients with higher levels of HER2 and HER2 homodimers correlated with
a higher probability of objective response (an endpoint in tumor
evaluation) to Herceptin therapy. In addition, those patients with higher
HER2 expression levels had a median time to progression of 11.6 months
while those in the lower half of the distribution had a median time to
progression of 5.4 months. This was also true of patients with higher
levels of HER2 homodimers who had a median time to progression of 11.6
months compared to those with lower HER2 levels who had a median time to
progression of 5.8 months. Further analysis revealed that there was a trend
in favor of higher HER2 expression and longer overall survival (median
survival 37.4 months vs. 28.7 months) although this was not statistically
significant (p=0.2). Finally, Cox multivariate analyses identified HER2
expression and HER2 homodimer levels as independent correlates of both time
to progression and overall survival.
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 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 potential
commercialization of the HERmark assay. 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 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@monogrambio.com 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 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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