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

BRUSSELS, IRVINE, California, and AMSTERDAM, October 18, 2011
(ots/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/MINDACTBroch
ure.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.

ots Originaltext: Agendia B.V.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For US media inquiries please contact: Ricochet Public Relations,
Valerie Carter, Tel: +1-202-316-0143
E-mail: agendia@ricochetpr.com