Aclara Biosciences (NASDAQ:ACLA)
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ACLARA BioSciences and Tokyo Metropolitan Institute of Medical
Science (Rinshoken) to Conduct Breast Cancer Biomarker Study
Focus on Indicators of Herceptin(R) Responsiveness
MOUNTAIN VIEW, Calif. and TOKYO, June 14 /PRNewswire-FirstCall/ -- ACLARA
BioSciences Inc. (NASDAQ:ACLA) and the Tokyo Metropolitan Institute of Medical
Science (Rinshoken) announced today that they have entered into an agreement to
collaborate on a study to evaluate breast cancer patient samples to validate
candidate biomarkers detected with ACLARA's proprietary eTag(TM) technology.
This study follows previously completed feasibility experiments on a small set
of tissue samples from patients treated with Genentech's drug Herceptin(R) and
chemotherapy.
The previous feasibility experiments were conducted on blinded sets of
formalin-fixed, paraffin-embedded tissue samples from thirteen breast cancer
patients treated with Herceptin and chemotherapy. All patients were positive
for the Her2 receptor (HercepTest(R) +3), the molecular target of Herceptin,
but not all responded to therapy. In this limited retrospective study,
ACLARA's eTag System was significantly better able to differentiate between
those patients whose disease had not progressed with treatment from those whose
disease had progressed than other methods employed. The encouraging results
from these experiments led ACLARA and Rinshoken to plan the larger study
covered by the new agreement.
As part of the agreement announced today, ACLARA will provide research funding
to Rinshoken and will have the ability to develop the biomarkers as clinical
diagnostics. Rinshoken's newly established Translational Research Center (TRC)
will coordinate the project which is the first collaboration between this
organization and a U.S. biotechnology company. Under the agreement, Rinshoken
will collect tumor samples and blinded patient data, including treatment
histories and outcomes, and ACLARA will test the samples for a variety of
parameters that it believes could serve as biomarkers of responsiveness to
certain targeted therapies, including Herceptin.
The biomarkers under evaluation are proteins and protein complexes and their
different functional or activation states that comprise signaling pathways in
cells. These pathways enable information transfer within and between cells and
control such processes as cell growth, division and death. When these pathways
malfunction, the affected cells can become cancerous, dividing uncontrollably.
Approved targeted therapies like Herceptin, and many more in development, act
on the proteins within these pathways. By measuring the targeted proteins and
pathways directly, ACLARA believes it can help physicians better determine
whether Herceptin or other therapies are most appropriate for treating an
individual cancer patient.
"We are very pleased to be collaborating with Rinshoken and its affiliated
hospitals," said Thomas Klopack, ACLARA's chief executive officer. "We are
very excited about the potential of these candidate biomarkers to help
physicians provide better care for patients. The critical information these
biomarkers can offer will permit the development of truly personalized
medicine. This project has grown from an initial successful feasibility study
conducted with Dr. Masakazu Toi at Komagome Hospital (Cancer and Infectious
Disease Center), and demonstrates the importance of the link between research
and clinical medicine to these types of advances. While the feasibility
experiments involved a limited number of patients, the preliminary results are
encouraging. The establishment of the Translational Research Center is a
progressive step by Rinshoken that will help to ensure that discoveries are
rapidly moved from the laboratory bench to the clinic."
Dr. Ken-ichi Arai, science advisor and director of Rinshoken, said, "We feel
that at this early stage in the TRC's development, it is important for the TRC
to initiate projects that have broad implications for medicine and patient
care. This project clearly falls into that category."
The TRC's director, Dr. Futoshi Shibasaki, commented, "Coordinating a project
that involves five different hospitals in the Tokyo Metropolitan government
system, as well as Rinshoken, is just the type of translational project the
Center was established to conduct. I look forward to a successful outcome, and
expect that it will pave the way for other interactions of this type."
ACLARA's eTag System is able to identify difficult-to-detect protein complexes
that can provide unique insights to the likelihood of particular patients to
respond to specific therapies. In addition, since the eTag System can utilize
formalin-fixed, paraffin-embedded clinical samples, the standard format in most
pathology labs, this enables the analysis of both archived samples from initial
biopsies or surgeries as well as freshly collected materials. The samples
being evaluated in this study are in the fixed format.
About Rinshoken
Rinshoken's activities cover a very wide area of clinical medicine and life
science research. It has made important contributions through research targeted
to investigating the causes as well as the diagnosis, treatment and control of
major diseases, including cancer, infectious diseases such as Hepatitis C and
genetic diseases. For example, it has aided efforts to control Hepatitis C
through important findings on the eradication of the Hepatitis B virus and the
first successful imaging of the Hepatitis C virus by electron microscopy.
About ACLARA
Founded in 1995, ACLARA is a biotechnology company working to provide
physicians and researchers products and services to make personalized medicine
a reality through its protein-based assay technology -- the eTag(TM) System.
ACLARA is dedicated to unlocking the power of pathway biology to accelerate the
development of next-generation targeted therapeutics, recognizing the most
appropriate patients for approved therapies and identifying the
highly-specific, protein-based biomarkers that will enable physicians to create
truly personalized treatment regimens for patients suffering from cancer and
other life-threatening disorders.
ACLARA is commercializing its proprietary eTag System to enhance and accelerate
drug discovery research and the preclinical and clinical development of
targeted therapeutics. ACLARA's technology may also enable the development of
highly specific, protein-based diagnostics capable of providing physicians with
a powerful tool for creating personalized treatment regimens for patients
suffering from serious and difficult-to-treat cancers. For more information on
ACLARA please visit the Company's web site at http://www.aclara.com/.
Forward-Looking Statements
All statements in this news release that are not historical are forward-looking
statements within the meaning of the Securities Exchange Act of 1934 as
amended. Such forward-looking statements are subject to factors that could
cause actual results to differ materially for ACLARA from those projected.
Those factors include risks and uncertainties relating to the performance of
our products, anticipated progress in commercialization of our eTag(TM) assay
system; the potential for use of our eTag assays in clinical development
programs; the potential for use of our eTag assays as diagnostic tests; our
ability to successfully conduct clinical studies and the results obtained from
those 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; our ability to develop organizational capabilities
suitable for the further development and commercialization of our eTag assays;
the ultimate validity and enforceability of our patent applications and
patents; the possible infringement of the intellectual property of others;
technological approaches of ACLARA and our competitors; our pending merger with
ViroLogic, Inc., including the risk that the closing conditions or the merger
may not be satisfied and the merger may not be completed, and costs related to
the proposed merger; and, other risk factors identified in our Form 10-Q for
the quarter ended March 31, 2004 as filed with the Securities and Exchange
Commission.
Trademarks
ACLARA BioSciences is a registered trademark, and eTag and the ACLARA logo are
trademarks of ACLARA BioSciences, Inc. Herceptin is a registered trademark of
Genentech, Inc. HercepTest is a registered trademark of DakoCytomation.
DATASOURCE: ACLARA BioSciences Inc.
CONTACT: investor, Alfred Merriweather, VP, Finance and CFO,
+1-650-210-1200, or ; or media, Jennifer Viera of Schwartz
Communications, +1-781-684-0770, or , for ACLARA
BioSciences Inc.
Web site: http://www.aclara.com/