- Data Expand Support for Development of
Diagnostic to Identify Patients With Biomarkers of Anti-Progestin
and Anti-Estrogen Activity -
- Bolster Findings Presented at ASCO and ECC 2013
-
Poster Session 6 Saturday, December 14; 7:30 - 9:00 a.m.
CT Abstract #1282 Poster #P6-05-13
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage
biopharmaceutical company focused on the development of oncology
therapeutics, today announced that data from a biomarker study
supporting its lead compound onapristone will be presented at a
poster session at the 2013 CTRC-AACR San Antonio Breast Cancer
Symposium (SABCS) annual meeting, being held December 10-14, 2013
in San Antonio, Texas. The symposium is hosted by the American
Association for Cancer Research, The Cancer Therapy & Research
Center at The University of Texas Health Sciences Center at San
Antonio, and Baylor College of Medicine.
Findings from the study "Tumor and Cellular Distribution of
Activated Forms of ERα and PR in Breast Cancers" (Abstract #1282)
will be presented during Poster Session 6 on Tumor Cell and
Molecular Biology: Biomarkers on Saturday, December 14 from 7:30 –
9:00 a.m. CT in Exhibit Hall C of the Henry B. Gonzalez Convention
Center. Data analysis from primary breast cancers further support
the development of a diagnostic test to identify patient tumors
with activated progesterone receptor (APR) and activated estrogen
receptor (AER) as potential biomarkers of anti-progestin and
anti-estrogen activity, respectively.
Onapristone is an oral, anti-progestin hormone blocker that has
been shown to have anti-tumor activity in breast cancer.
Onapristone appears to have a unique ability to block the APR,
which is believed to be a mechanism that may inhibit the growth of
breast, endometrial and other tumors. APR has the potential to
function as a biomarker of anti-progestin activity.
Poster Title: Tumor and cellular distribution of
activated forms of ER and PR in breast cancers
Study Authors: Bonneterre J, Bosq J, Valent A, Gilles E,
Zukiwski A.
The study evaluated 397 archived breast cancer tumor specimens
and aimed to describe and quantify the histological sub-nuclear
morphology of activated and inactive progesterone receptor (PR) and
estrogen receptor (ER) using an immunohistochemical (IHC)
diagnostic technique to identify the activated forms of steroid
receptors as well as analyze the relationship between activated PR
and ER, and relate them via multivariate analysis to anti-estrogen
treatment outcomes.
Progesterone and estrogen receptors can be categorized into two
patterns, non-activated and activated, depending upon the
sub-nuclear morphological distribution of the receptors. There are
two isoforms of PR, PRA and PRB, and balanced expression is
observed in normal human tissues, while deregulated expression is
observed in malignant tissues; some cancers may express only PRA or
PRB. The tumor specimens were analyzed with isotype-specific
antibodies for ERα (a subtype of ER), PRA or PRB.
The study evaluated 397 archived breast cancer specimens from
consenting women with invasive ductal breast cancer from Oscar
Lambret Cancer Center in Lille, France. Of these specimens, 365
were from patients with early stage disease, and the majority of
the patients had received prior anti-estrogen/aromatase
inhibitors.
In this series of primary breast cancer, IHC staining
demonstrated that 19 percent of tumors are PR negative, 18 percent
are ERα negative and 12 percent are both PR and ERα negative. The
study also concluded that breast cancer tumors commonly express
both ERα and PR, but co-expression in malignant cells is relatively
uncommon (median 4% of cells). The same applies to the activated
forms of the receptors. In addition, determination of PR by
isotype-specific antibodies for PRA and PRB demonstrated a higher
incidence of PR expression in this series than that described in
the literature.
The study found that the activated form of the steroid receptors
are present in 18 percent of tumors for AERα, 18 percent of tumors
for APR and 13 percent of tumors for both AERα and APR.
The study also found that PR positivity correlates with better
outcomes, while the activated form of the PR does not appear to
correlate with anti-estrogen treatment outcomes. The authors
concluded that activated PR does not predict for treatment outcome
with anti-estrogens and aromatase inhibitors in patients with early
stage breast cancer. Activated PRA may correlate with better
outcomes similarly to ERα, while activated PRB appears associated
with worse outcomes, suggesting that PRB has a different role than
PRA.
However, ERα positivity correlates with better outcomes while
the activated form of the ERα significantly correlates with better
outcomes, as confirmed by logistic regression analysis. This led
the authors to conclude that activated ERα may correlate with
improved outcomes from anti-estrogen and aromatase inhibitor
treatment. If this exploratory analysis is confirmed,
determination of the activated form of ERα may indicate which
patients with early breast cancer are most likely to benefit from
long term aromatase inhibitor or anti-estrogen treatment.
The authors concluded that activated forms of ERα and the PRs
are independent targets at the cellular and tumor level and
therefore activated ERα and the PRs may be suitable markers for
tailoring treatment with anti-estrogens and anti-progestins.
"These data demonstrate the potential of two predictive
biomarkers in the treatment of breast cancer and further support
the development of a diagnostic test to identify patients with
activated progesterone receptor (APR) and activated estrogen
receptor (AER) most likely to respond to treatment with
anti-progestins and anti-estrogens, respectively," said Glenn
Mattes, President and Chief Executive Officer of Arno Therapeutics.
"We are encouraged by these results and continue to move forward in
a clearly-defined development program for our lead compound
onapristone and an accompanying companion diagnostic."
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 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 potential of
APR and AER as effective biomarkers for the treatment of breast
cancer, statements regarding the Company's belief that onapristone
blocks the APR, 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 statements
regarding 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
Arno Therapeutics
Glenn Mattes
gm@arnothera.com
(862) 703-7176
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