Arno Therapeutics Initiates Pharmacokinetic Study for Onapristone Following Regulatory Acceptance
August 21 2013 - 9:06AM
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage
biopharmaceutical company focused on the development of oncology
therapeutics, today announced it has initiated a pharmacokinetic
(PK) study of onapristone. The initiation follows the submission
and approval of an Investigational Medicinal Product Dossier (IMPD)
by the French Health Authority, L'Agence Nationale de Sécurité du
Médicament et des Produits de Santé (ANSM).
Onapristone is an 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 (PR), which is believed to be the mechanism
that may inhibit the growth of breast, endometrial and other
tumors.
Mr. Glenn Mattes, Chief Executive Officer and President of Arno
Therapeutics, stated, "This significant milestone marks the
advancement of our clinical program for our lead candidate
onapristone. We initiated the PK study less than two weeks
after receiving IMPD approval in late July and are on track to
commence the Phase 1 trial in patients with PR positive tumors
later this year."
The PK study is designed to recruit twelve healthy volunteers.
It will investigate the pharmacokinetic parameters and
examine the effect of food on the absorption of onapristone.
All volunteers will receive 10 mg of onapristone, receiving
the drug after fasting or with food.
The Company has selected Biotrial, a drug evaluation and
pharmacology research company, as its contract research
organization (CRO) for this trial. The PK study will be
conducted by Biotrial's clinical unit in Paris, France.
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, Arno's use of the diagnostic test being developed with
Veridex in its planned Phase I trial 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 any of our other product candidates, 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
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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