|Creating the next generation of cancer treatments
August 21, 2013
Arno Therapeutics Initiates Pharmacokinetic Study for Onapristone Following Regulatory Acceptance - Biotrial to Serve as Contract Research Organization for Paris-Based Trial
FLEMINGTON, NJ - August 21, 2013 - 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.The Ruth Group
Stephanie Carrington (investors)
Kirsten Thomas (media)
Arno Therapeutics, Inc.