Monogram Announces HERmark(TM) Oral Presentation at the 44th ASCO Annual Meeting
May 16 2008 - 12:02PM
PR Newswire (US)
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 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, +1-415-677-2700, , for Monogram Biosciences, Inc. Web
site: http://www.monogrambio.com/
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