Arno Therapeutics Enrolls First Patient in a Phase I Trial to Evaluate Lead Compound Onapristone in Progesterone Receptor Pos...
January 21 2014 - 12:06PM
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage
biopharmaceutical company focused on the development of oncology
therapeutics, today announced that it has enrolled the first
patient in a Phase I dose escalation study evaluating onapristone
in post-menopausal women with progesterone receptor (PR) positive
tumors, including breast, endometrial and other solid tumors. The
Phase I trial is designed to identify the recommended Phase II dose
and determine the overall safety profile of onapristone.
Onapristone has the potential to be the first approved
anti-progestin for oncology indications and provide
chemotherapy-sparing treatment to cancer patients who express a
specific biomarker, as detected by a companion diagnostic under
development. Onapristone is an oral, anti-progestin hormone blocker
that has been shown in previous Phase II clinical trials to have
anti-tumor activity in patients with breast cancer. In extensive
pre-clinical testing, onapristone has demonstrated the ability to
block the activation of the progesterone receptor. This mechanism
is believed to inhibit the growth of breast, endometrial and other
tumors. The activated form of the progesterone receptor (APR)
has the potential to function as a biomarker of anti-progestin
activity.
The Phase I study will evaluate onapristone in sustained release
and immediate release formulations in up to six dose levels (10-50
mg BID and 100 mg QD) to identify the recommended Phase II dose. In
addition, the study will gather data showing antitumor
activity. This multi-site trial is taking place in France and
expected to enroll a total of 60 patients. The first patient has
been enrolled by investigator Andrea Varga, MD at Gustave Roussy
Institute of Oncology, Villejuif, France.
Arno has engaged Biotrial, a drug evaluation and pharmacology
research company that conducted the pharmacokinetic (PK) study, as
its contract research organization for the Phase I trial.
Glenn Mattes, President and Chief Executive Officer of Arno
Therapeutics, remarked, "The enrollment of the first patient in
this Phase I trial is a tremendous milestone for Arno and is
testament to the considerable strides we have made in the past
year. We are focused on driving forward the development of
onapristone in the most efficient and cost-effective manner and
believe it could fill a unique position in the market as there is
significant potential for it be the first approved anti-progestin
in oncology. We are at the forefront of establishing a genuine
appreciation for the role of the progesterone receptor in cancer
and the activated form as a biomarker, and we look forward to
successfully developing our program."
Alex Zukiwski, MD, Chief Medical Officer of Arno Therapeutics,
said, "Through a clearly defined development pathway, our initial
strategy is to target the activated form of progesterone receptor
positive cancers in two indications with high unmet medical need –
endometrioid cancer and castration-resistant prostate cancer.
Through preclinical work, we've established that a significant
percentage of endometrioid cancer tumor specimens are APR positive.
The goal of the Phase I study underway is to determine the
recommended dose for onapristone that we can utilize for a Phase II
trial of patients with recurrent or metastatic endometrioid
cancer."
About Endometrial Cancer
In the United States, about 49,500 cases of cancer of the
uterine corpus (endometrium) - the body of the uterus - were
expected to be diagnosed in 2013 and typically occur in the
endometrium (lining of the uterus). About 8,200 deaths were
expected in 2013.i
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 were 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 were 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 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
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
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