Poster Session: Diagnostics/Biomarkers, Hall 4 Abstract
#1001; Poster #258 Abstract #1002; Poster #274
- Underscores role of
anti-progestins - - Supports further evaluation of onapristone and
development of companion diagnostic - - Expands on findings
presented at ASCO 2013 -
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage
biopharmaceutical company focused on the development of oncology
therapeutics, today announced data from two preclinical studies
supporting its lead compound onapristone to be presented at poster
sessions at the European Cancer Congress (ECC) 2013 Annual Meeting,
being held September 27-October 1, 2013 in Amsterdam, Netherlands.
ECC incorporates three conferences – ECCO, ESMO and ESTRO.
The findings, which are summarized below, will be presented
during the Diagnostics/Biomarkers poster session on Saturday,
September 28 from 8:00 – 10:30 a.m. EDT (14:00 - 16:30 CEST) in
Hall 4 of the Amsterdam RAI Exhibition and Convention Centre. The
two separate preclinical studies further support the development of
a diagnostic test to identify patients with activated progesterone
receptor (APR) in tumor specimens as a potential biomarker of
anti-progestin activity.
Onapristone is an oral, anti-progestin hormone blocker that has
been shown to have considerable anti-tumor activity in breast
cancer. Onapristone appears to have a unique ability to block the
activated progesterone receptor (APR), which is believed to be a
mechanism that may inhibit the growth of breast, endometrial and
other tumors. The APR has the potential to function as a biomarker
of anti-progestin activity.
"These findings are an expansion of the data set presented at
the American Society of Clinical Oncology (ASCO) meeting earlier
this year and further support the activated form of progesterone
receptor as a target for treatment with an anti-progestin," said
Alex Zukiwski, Chief Medical Officer of Arno Therapeutics and one
of the authors for study abstract #1001. "With the development of a
commercially-viable diagnostic test to recognize APR positive
tumors, we will be able to identify the patients most likely to
respond to treatment with onapristone, which is moving toward a
Phase I trial."
- Clinical and pathological correlation of the activated
form of the progesterone receptor (PR) in breast cancer
(BC) Abstract #1001; Poster #273 The
study evaluated 397 archived breast cancer samples to correlate the
APR status (PR nuclear morphology) using immunohistochemistry (IHC)
in BC biopsies to any clinical and/or pathological relationships.
APR positive was defined as any tumor with more than 5 percent APR
cells. The study found two distinct PR nuclear distribution
patterns, an aggregated pattern (A) indicative of activated PR and
a diffused, or finely granular pattern, (D) reflecting inactive
PR.
The study concluded that although there was an association with
higher tumor grade, the APR status was not clearly linked or
associated with other prognostic variables such as clinical
characteristics, markers for proliferation, estrogen receptor (ER),
PR positivity or disease stage. This indicated that APR cannot be
predicted by routine clinical data or pathological testing.
Overall, the study established that further work on the APR is
warranted, as the biomarker has the potential to determine which
patients could benefit from anti-progestin treatment. Arno is
currently developing a companion diagnostic to identify APR in
solid tumors.
- Clinical and pathological correlation of the activated
form of the progesterone receptor (APR) in endometrial cancer
(EC) Abstract #1002; Poster
#274 The study evaluated 76 archived
endometrial cancer samples using a standard IHC technique to
determine the APR status in EC and to describe any clinical or
pathological relationships with the ultimate goal of developing a
companion diagnostic predicting the efficacy of anti-progestins in
patients with EC.
The study suggests PR is constitutively active in a subset of
endometrial tumors, but not in normal tissue. In such cases,
investigation of anti-progestin treatment is warranted as it could
inhibit tumor PR activity to disrupt any PR-driven proliferation.
The study also concluded that detection of APR can be potentially
performed in a routine clinical diagnostic setting, and that APR
detection in endometrioid cancer is potentially valuable to
identify patients who may benefit from anti-progestin
treatment.
These findings support further evaluation of APR as a target for
treatment with an anti-progestin, such as onapristone.
"This data underscores the role of anti-progestins and supports
using APR as a biomarker in solid tumors. We are moving forward in
parallel the development of the diagnostic test and the clinical
development of onapristone," remarked Glenn Mattes, President and
Chief Executive Officer of Arno Therapeutics.
Recently, Arno Therapeutics initiated a pharmacokinetic study in
healthy volunteers and is moving toward its first Phase I trial
with the submission of an Investigational Medicinal Product Dossier
(IMPD) to the French Health Authority, L'Agence Nationale de
Sécurité du Médicament et des Produits de Santé (ANSM), to request
the clinical trial authorization of a Phase I dose escalation study
evaluating onapristone.
About Breast Cancer
In the United States, over 232,300 new cases of invasive breast
cancer are expected to be diagnosed in women and over 2,200 new
cases are expected in men during 2013. After cancers of the skin,
breast cancer is the most frequently diagnosed cancer in women.
More than 40,000 breast cancer deaths are expected in 2013, with
the majority in women. Breast cancer ranks second as a cause of
cancer death in women, following lung cancer.i
About Endometrial Cancer
In the United States, about 49,500 cases of cancer of the
uterine corpus (endometrium) - the body of the uterus - are
expected to be diagnosed in 2013 and typically occur in the
endometrium (lining of the uterus). About 8,200 deaths are expected
in 2013.i
About Arno Therapeutics
Arno Therapeutics is a clinical stage biopharmaceutical company
developing innovative products for the treatment of cancer. Arno
has exclusive worldwide rights to develop and market three
innovative anti-cancer product candidates. These compounds are in
clinical or preclinical development as product candidates to treat
hematologic malignancies and solid tumors. For more information
about the company, please visit www.arnothera.com.
Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. These statements are
often, but not always, made through the use of words or phrases
such as "anticipates," "expects," "plans," "believes," "intends,"
and similar words or phrases. These forward-looking statements
include, without limitation, statements regarding the timing,
progress and anticipated results of the clinical development of
onapristone, statements regarding Arno's use and development of a
diagnostic test to identify patients with APR tumors, as well as
Arno's strategy, future operations, outlook, milestones, future
financial position, future financial results, plans and objectives.
We may not actually achieve these plans, intentions or expectations
and Arno cautions investors not to place undue reliance on our
forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements we make. Various important factors
could cause actual results or events to differ materially from the
forward-looking statements that we make. Such factors include,
among others, risks that the results of clinical trials will not
support our claims or beliefs concerning the effectiveness of
onapristone or any of our other product candidates, our ability to
successfully develop a diagnostic to identify APR tumors, our
ability to finance the development of our product candidates,
regulatory risks, and our reliance on third party researchers and
other collaborators. Additional risks are described in the
company's Annual Report on Form 10-K for the year ended December
31, 2012. Arno is providing this information as of the date of this
press release and does not undertake any obligation to update any
forward-looking statements as a result of new information, future
events or otherwise.
_________________________________________ i
American Cancer Society. Cancer Facts &
Figures 2013. Available at:
http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf
Last accessed: September 25, 2013.
CONTACT: The Ruth Group
Stephanie Carrington (investors)
scarrington@theruthgroup.com
(646) 536-7017
Kirsten Thomas (media)
kthomas@theruthgroup.com
(646) 536-7014
(508) 280-6592 (mobile)
Arno Therapeutics
Glenn Mattes
gm@arnothera.com
(862) 703-7176
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