Arno Therapeutics Selects Leica Biosystems to Develop Companion Diagnostic for Targeted Oncology Therapy Onapristone
January 07 2014 - 8:15AM
Arno Therapeutics, Inc. (OTCQB:ARNI); (Arno), a clinical stage
biopharmaceutical company focused on the development of oncology
therapeutics, and Leica Biosystems (LBS), a global leader in
pathology workflow solutions and automation, announced that the
companies have entered into a co-development agreement for the
development of a companion diagnostic (CDx) for Arno's lead
compound and personalized therapy, onapristone.
Onapristone is an oral, anti-progestin hormone blocker that has
been shown to have anti-tumor activity in breast cancer.
Onapristone appears to selectively block the activation of the
progesterone receptor (APR). This is believed to inhibit the growth
of APR-driven breast, endometrial and other tumors.
The CDx will be an immunohistochemical (IHC) in vitro diagnostic
(IVD) test used to detect APR in various women's cancers, including
endometrioid and breast cancer. This CDx test will help to identify
patients who are APR positive and therefore most likely to respond
to treatment with onapristone. This also has potential application
in castration-resistant prostate cancer (CRPC).
In preclinical work sponsored by Arno, IHC testing on archived
specimens has shown that approximately 40% of archived endometrioid
cancer specimens and approximately 25% of archived breast cancer
specimens were APR positive. Initial findings by Arno indicate that
progesterone receptor (PR) was present in CRPC specimens and
potentially active in a subset of tumors. Further investigation is
underway to determine the frequency of APR positive tumors in CRPC
specimens.
Under the terms of the co-development agreement, Arno will
sponsor and conduct clinical trials for onapristone. Leica will
develop and validate the CDx for APR with responsibility for
ensuring the investigational CDx kit is ready, available and meets
FDA and other health authority standards for a planned Phase II
trial of onapristone in endometrioid cancer. The co-development
program aims to achieve simultaneous approval and launch of
onapristone and the CDx IVD for APR.
"This agreement with Leica Biosystems is a significant milestone
for Arno and an important step forward in the development of
onapristone. We believe that partnering with a world-class
organization such as Leica will enable us to quickly and
effectively get to reliable, reproducible and practical APR
positive tumor detection. This will help identify the patients most
likely to benefit from treatment with onapristone," said Glenn
Mattes, Chief Executive Officer of Arno Therapeutics. "We are
excited about what the future holds for Arno as we enter a critical
period for the Company with the commencement of our first Phase I
trial which will evaluate onapristone in progesterone receptor
positive tumors."
"We are pleased to partner with Arno to co-develop this
companion diagnostic for onapristone," added Dr. Matthias Weber,
President of Leica Biosystems. "Personalized medicine is a key
development in oncology. We believe that diagnostics such as the
APR test will play a critical role in the broader effort to improve
quality of care for patients."
About Leica Biosystems
Leica Biosystems is a global leader in pathology workflow
solutions and automation, striving to advance cancer diagnostics to
improve lives. Leica Biosystems provides anatomical pathology
laboratories and researchers a comprehensive product range for each
step in the pathology process, from sample preparation and staining
to imaging and reporting. Leica's easy-to-use and consistently
reliable offerings help improve workflow efficiency and diagnostic
confidence. Further information can be found at
www.LeicaBiosystems.com.
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, the ability of the CDx under development with Leica
Biosystems to help identify patients who are APR positive and
Arno's use of the CDx in its clinical development program of
onapristone, 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 the CDx to
be developed for use with onapristone, 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.
CONTACT: The Ruth Group
Lee Roth (investors)
lroth@theruthgroup.com
(646) 536-7012
Kirsten Thomas (media)
kthomas@theruthgroup.com
(646) 536-7014
Arno Therapeutics
Glenn Mattes
gm@arnothera.com
(862)-703-7176
Arno Therapeutics (CE) (USOTC:ARNI)
Historical Stock Chart
From May 2024 to Jun 2024
Arno Therapeutics (CE) (USOTC:ARNI)
Historical Stock Chart
From Jun 2023 to Jun 2024