Arno Therapeutics Granted Exclusive License for Oncology Diagnostic Technique by University of Minnesota

Potential to Identify Pathway Activity in Tumor Samples Increases Ability to Select Patients Most Likely to Benefit From Onapristone

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| Source: Arno Therapeutics Inc.

FLEMINGTON, N.J., March 4, 2014 (GLOBE NEWSWIRE) -- Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that it has signed an exclusive, worldwide license agreement with the University of Minnesota for technology related to a gene expression signature derived from archived breast cancer tissue samples. This technique has the potential to identify progesterone-stimulated pathway activation and in turn, help identify patients who would most likely benefit from treatment with Arno's lead compound, onapristone, an anti-progestin therapeutic aimed at treatment of men's and women's cancers.

Glenn Mattes, Chief Executive Officer of Arno Therapeutics, remarked, "Our agreement with the University of Minnesota offers Arno a strategic partnership with a leading academic institution and innovator in research, education and patient care in the oncology space. This technology gives Arno an additional platform for identifying patients with cancer who would most likely benefit from our personalized therapy."

The principal objective of gene expression studies is to identify one or more gene signatures in breast and other tumor types, genes whose transcriptional levels are uniquely associated with a specific biological phenotype.i Ideally, this gene signature, which indicates the presence of aberrant progesterone receptor activity, can then be used to select a patient population with cancer that are more likely to benefit from anti-progestin therapy.

Onapristone is an oral, anti-progestin hormone blocker that has been shown in previous Phase II clinical trials to exhibit anti-tumor activity in patients with breast cancer. In pre-clinical testing, onapristone has been shown to block the activation of the progesterone receptor (PR), which is believed to be a mechanism that inhibits the growth of APR-driven breast, endometrial and other tumors. Tests for the activated form of the progesterone receptor (APR) have the potential to function as a biomarker of anti-progestin activity, as detected by a companion diagnostic under development. Onapristone is currently being evaluated in a phase I clinical trial in women who have progesterone receptor expressing tumors in France.

Under the agreement, negotiated through the University's Office for Technology Commercialization, with the University of Minnesota, Arno will further develop the PR gene signature as a potentially predictive companion diagnostic for anti-progestins, including onapristone. The agreement enables the potential of incorporating such a companion diagnostic test into ongoing and future clinical studies of onapristone.

Carol Lange, PhD, Professor of Medicine, University of Minnesota, commented, "As progesterone receptors are implicated in cancer progression, we are excited by the possible outcomes resulting from investigation of the PR gene signature in breast cancer tissue samples, as illustrated by the expression pattern. The study of this gene signature may enable better, more targeted selection of patient candidates who will benefit most from anti-progestin therapeutics such as onapristone. We believe that the advent of personalized medicine in oncology represents a meaningful advancement in the area of cancer therapeutics. Onapristone is specifically aimed at targeting the aberrant actions of progesterone receptors. The potential development of a companion diagnostic for Arno's lead compound from this technology represents a significant step forward in our ability to truly realize the potential of personalized medicine."  

David M. Jackson, Vice President, Diagnostics of Arno Therapeutics, noted, "Onapristone, a member of the class of anti-progestins, has the distinct ability to block the activation of the progesterone receptor. We believe this license agreement will enable Arno's diagnostic strategy to identify and develop multiple analytical methods to identify those patients whose tumors are APR-positive and may therefore benefit from targeted onapristone therapy."

About the University of Minnesota

Founded in 1851, the University of Minnesota is a land-grant institution, committed to illuminating and engaging Minnesota and other communities to advance interdisciplinary knowledge and benefit society; enhance students' academic, civic, career, social and personal development; and engage intellectual and human capital to serve the public good. Ranked consistently among the top public research universities nationally, it is also among the country's most comprehensive institutions.

About the Office for Technology Commercialization

The Office for Technology Commercialization oversees all aspects of technology commercialization at the University of Minnesota. Its mission is to translate University research into new products and services that provide growth opportunities for its licensees, benefit the public good, improve the quality of life and generate revenue to support the University's research and education goals. Learn more at: research.umn.edu/techcomm.

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 the technology licensed from the University of Minnesota to identify patients most likely to benefit from onapristone, statements regarding the timing, progress and anticipated results of the clinical development of onapristone, the ability of the CDx under development to help identify patients who are APR positive, 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, the newly-acquire gene expression signature technology 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. 

i National Center for Biotechnology Information (NCBI), U.S. National Library of Medicine. "GeneSigDB—a curated database of gene expression signatures." Nucleic Acids Research. Jan 2010; 38 (Database issue): D716–D725. Published online Nov 24, 2009. doi:  10.1093/nar/gkp1015. Available online at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2808880/

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