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EORTC, BIG, and Agendia Announce Completion of Patient Recruitment for International MINDACT Study

October 18, 2011

BRUSSELS, IRVINE, California, and AMSTERDAM, October 18, 2011 /PRNewswire/ –

The EORTC, BIG, and Agendia, a commercial-stage molecular cancer
diagnostics company, today announced the completion of patient registration
for the EORTC 10041/BIG3-04 MINDACT (Microarray In Node negative and 1-3
positive lymph node Disease may Avoid Chemotherapy Trial) study. More than
6,600 patients in 111 institutions across nine countries were enrolled from
February 2007 to July 2011 in this trial.

Genomic risk profiling lies at the heart of personalized management of
cancer. MINDACT is investigating the added clinical value of MammaprintTM to
standard clinicopathological criteria for the accurate selection of breast
cancer patients for adjuvant chemotherapy. The study aims to provide further
evidence that early breast cancer patients with a low recurrence risk
genomic profile by Mammaprint(R) may not need chemotherapy. This would spare
patients from burdensome side effects without increasing the risk of
metastasis or reducing survival. The study is also designed to show whether
MammaPrint(R) can predict patient response to specific therapies.

Commercialized by Agendia, MammaPrint(R) has been cleared by the FDA as
a prognostic tool identifying patients at low risk of metastasis, and can
already be used across the spectrum of breast cancer cases for this purpose
(including ER positive and negative, and lymph node negative and positive).
It is being tested in MINDACT to provide large-scale prospective validation
of its clinical utility.

“The completion of patient recruitment is a major milestone for this
groundbreaking trial. If MammaPrint(R) is ultimately shown to predict
individual patient response to the trial specific cancer therapies currently
on the market, it will likely create significant and valuable synergies for
the manufacturers of these drugs by improving treatment success rates,” said
Bernhard Sixt, CEO and co-founder of Agendia. “In addition, MINDACT will
likely generate new specific companion diagnostics that can be added to
MammaPrint(R) in Agendia’s Symphony(TM) decision support system to further
improve its clinical value.”

According to the MINDACT principal investigators (Drs Emiel Rutgers,
Martine Piccart, and Fatima Cardoso), “The enthusiasm and commitment of all
the many people involved in MINDACT – surgeons, pathologists, medical
oncologists, research nurses and patients – have proven the doubters wrong.
We are delighted to be able to show that it is possible to conduct such a
complex international trial in a short period of time, and are convinced
that MINDACT, with its rich collection of biological and clinical data, will
nurture breast cancer research for years to come.”

MINDACT is the largest European randomized prospective trial evaluating
the clinical value of a genomic profile for risk assessment and adjuvant
chemotherapy prescription for breast cancer. The trial’s complex logistics,
including real-time collection of frozen tumor tissue, were proven feasible
in a multinational, multicenter setting. Based upon patients’ risk of
recurrence classification by MammaPrint(R) and clinicopathological criteria,
they are offered adjuvant chemotherapy (a non-mandatory randomisation
between commonly administered anthracycline-based regimens and the study
combination of docetaxel plus capecitabine). Endocrine treatment is also
offered to the patients whose tumors express hormone receptors (a
non-mandatory randomisation between letrozole and tamoxifen followed by
letrozole). The entire genomic profile of each patient’s tumor is also being
analyzed, and this could allow research groups involved in the consortium to
find new, specific companion diagnostics for the drugs administered in the
trial. Agendia holds exclusive commercial rights to new RNA-based companion
diagnostics that result from the trial but research using biological samples
/ clinical data is open to the entire scientific community.

About MINDACT

Coordinated by the European Organisation for Research and Treatment of
Cancer (EORTC) and run under the BIG/TRANSBIG networks, MINDACT aims to
provide confirmatory evidence that patients with a low recurrence risk
signature by Mammaprint(R) may be spared chemotherapy and its burdensome
side effects, without negative repercussions on survival rate. MINDACT,
which involved sites in the Netherlands, France, Germany, Belgium, Spain,
Italy, UK, Slovenia, and Switzerland, began recruiting patients in 2007 and
its first results are expected in approximately three years.

Ancillary research is led by TRANSBIG, a consortium launched by BIG
(Breast International Group) in 2004 and supported by the European Union’s
6th Framework Program to promote international collaboration in
translational research. Further research grants have been received from the
Breast Cancer Research Foundation, Novartis, F. Hoffman La Roche,
Sanofi-Aventis, the National Cancer Institute (NCI), the EBCC-Breast Cancer
Working Group, the Jacqueline Seroussi Memorial Foundation, Prix Mois du
Cancer du Sein, Susan G. Komen for the Cure, Fondation Belge Contre le
Cancer, Dutch Cancer Society (KWF), Association Le Cancer du Sein,
Parlons-en!, Deutsche Krebshilfe and the Grant Simpson Trust and Cancer
Research UK. Whole genome analysis is provided in kind by Agendia.

This trial would not have been possible without such support and the
collaboration of hundreds of healthcare professionals across multiple
disciplines, and above all without the trust and participation of all the
patients.

For more information on MINDACT please visit:

http://www.breastinternationalgroup.org/Publications/MINDACTBrochure.aspx

About the EORTC

Founded in 1962, the EORTC is a nonprofit international cancer research
organization under Belgian law. The EORTC has the mission to develop,
conduct, coordinate and stimulate translational and clinical research in
Europe to improve the management of cancer and related problems by
increasing survival but also patient quality of life. The EORTC is both
multinational and multidisciplinary, and the EORTC Network comprises over
300 hospitals and cancer centers in over 30 countries which include some
2,500 collaborators from all disciplines involved in cancer treatment and
research.

For more information about the EORTC please visit:

http://www.eortc.be

About the BIG

BIG is a non-profit organization for academic breast cancer research
groups from around the world, headquartered in Brussels, Belgium. Founded in
1999, BIG comprises 50 groups based in Europe, Canada, Latin America, Asia
and Australasia, representing several thousand specialized hospitals and
research centers. BIG also works closely with the US National Cancer
Institute and the North American Breast Cancer Groups. To make significant
scientific advances in breast cancer research, reduce unnecessary
duplication of effort, and optimally serve patients, large-scale
collaboration is crucial. Therefore BIG facilitates breast cancer research
by stimulating cooperation between its members and other academic networks,
and partnering with, but working independently from, the pharmaceutical
industry.

For more information about BIG please visit:

http://www.breastinternationalgroup.org

About Agendia:

Agendia [http://www.agendia.com ] is a leading global commercial
molecular diagnostic company that develops and markets genomic-based
diagnostic products that improve the quality of life for cancer patients and
simplifies complex treatment decisions for their physicians. Agendia’s
Symphony(TM) suite of breast cancer products is based on the analysis of
hundreds of genes in a patient’s breast and provides unprecedented
biological insight to address complex treatment decisions. Symphony(TM)
includes MammaPrint(R), the first and only FDA-cleared IVDMIA breast cancer
recurrence assay, as well as BluePrint(R), a molecular subtyping assay,
TargetPrint(R), an ER/PR/HER2 expression assay, and TheraPrint(R), a therapy
selection assay. Together, these tests help physicians determine a patient’s
individual risk for metastasis, which patients will benefit from chemo or
hormonal therapy, and which patients do not require these treatments and can
instead be treated with other less arduous and costly methods.

In addition to the Symphony(TM) suite of tests, Agendia has a rich
pipeline of genomic products in development based on its world-class genomic
platform. The company also collaborates with pharmaceutical companies to
develop companion diagnostic tests in the area of oncology and is a critical
partner in the ISPY-2 and MINDACT trials.

Agendia was founded in 2003 as a spin-off of the Netherlands Cancer
Institute and is based in Amsterdam, the Netherlands, and Irvine,
California, United States.

For more information about Agendia please visit:

http://www.agendia.com.

SOURCE Agendia B.V.


Source: PR Newswire