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PRESS RELEASES



May 14, 2014

Arno Therapeutics to Outline Two Phase I Studies Evaluating Onapristone in Men’s and Women’s Cancers at 2014 ASCO Annual Meeting
- Studies to determine recommended Phase II dose and safety profile of lead compound -
- Will analyze relationship of biomarker to any anti-tumor activity observed -


FLEMINGTON, NJ - May 14, 2014 - Arno Therapeutics, Inc. (OTCQB: ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced two, separate abstracts outlining the study designs of ongoing Phase I clinical trials evaluating its investigational lead compound onapristone to be presented at the upcoming 50th American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 30 – June 3, 2014 in Chicago, Illinois. Arno will present the objectives, methods and study designs for its two ongoing studies, a Phase I trial in women with progesterone receptor (PR) expressing tumors and a Phase I/II trial in men with advanced castration-resistant prostate cancer (CRPC), who have failed treatment with abiraterone or enzalutamide. Each study is two-stage with an expansion component; the first stage evaluates dose selection and the second expands the number of patients at the determined recommended Phase II dose to confirm the safety profile and provide a preliminary assessment of anti-tumor activity. “The strategically-planned study designs of both trials enable us to advance the clinical evaluation of targeted therapy onapristone with the goal of determining the recommended Phase II dose and safety profile in the most efficient and effective means possible,” said Glenn Mattes, President and Chief Executive Officer of Arno Therapeutics. “Perhaps even more importantly, we intend to analyze the relationship of the biomarker, that being the activated form of the progesterone receptor, to any anti-tumor activity that is observed. Earlier this year, we began actively enrolling patients in both trials and also began the development of a companion diagnostic for the selection of patients more likely to benefit from treatment with onapristone. We are encouraged by the significant potential of onapristone to be a first-in-class anti-progestin compound for oncology indications.” The designs, outlined below from the accepted abstracts, will be presented during two separate poster sessions:

A randomized, parallel-dose Phase I study of onapristone (ONA) in patients (pts) with progesterone receptor (PR)-expressing cancer i

Abstract:TPS2643
Poster:98B
General Poster Session:Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics
Date, Location:Sunday, June 1, 8:00 AM - 11:45 AM; S Hall A2
The multi-center, open-label, randomized, parallel-dose Phase I study is an active, two-stage study with an expansion component in a total of about 60 women with tumors expressing PR. Tumor tissue is required to determine PR and transcriptionally activated PR (APR) status. The primary endpoint of the study is to determine the recommended Phase II dose (RP2D) of extended-release onapristone, including a period for observation of dose-limiting toxicity. Secondary endpoints include safety and tolerability, efficacy, and real-time pharmacokinetic (PK) data. In addition, tissue specimens will be used to determine relationship of APR to preliminary efficacy. Actively enrolling, dose-escalation Stage 1 of the trial evaluates six dose cohorts randomized in parallel. In each cohort, six patients receive extended release onapristone tablets at one of five doses (10, 20, 30, 40 or 50 mg BID) or immediate-release onapristone tablets at 100 mg QD until progressive disease or intolerable safety. A data review committee (DRC) monitors safety signals and dose limiting toxicities. Stage 2 of the study will enroll an additional 24 patients at the RP2D; this cohort will confirm the safety profile and potentially provide a preliminary assessment of anti-tumor activity. The DRC will continue to review all safety, PK and efficacy data.

A Phase I-II study of the type I progesterone receptor (PR) antagonist onapristone (ONA) in patients (pts) with advanced castration-resistant prostate cancer (CRPC)ii

Abstract:TPS5097
Poster:224B
General Poster Session:Genitourinary (Prostate) Cancer
Date, Location:Monday, June 2, 1:15 PM - 5:00 PM; S Hall A2
The open-label, Phase I/II study is an active, two-stage study with an expansion component in a total of about 60 men with metastatic or recurrent advanced castration-resistant prostate cancer (CRPC) who have failed treatment with abiraterone or enzalutamide. Because PR expression in prostate cancer increases with resistance to castration, the transcriptional, activated PR (APR) offers a potential target in advanced CRPC. Patients are evaluated at baseline to determine PR status and paired biopsies at day eight through 28 and upon progression are collected if possible. The primary endpoints of this study include, determination of the RP2D and response rate based on Response Evaluation Criteria In Solid Tumors (RECIST) rules, circulating tumor cell (CTC) count conversion and/or more than 50% decline in prostate-specific antigen (PSA), a protein indicative of prostate cancer. Secondary endpoints include safety and PK data. Currently enrolling, dose-selection Stage 1 evaluates patients randomized to 10 or 20 mg of extended release onapristone tablets BID, with three to six patients per cohort. Upon confirmation of safety, based on a dose-limiting toxicity (DLT) observation period of eight weeks, a data review committee (DRC) will open randomization in parallel to the 30, 40 or 50 mg cohorts, with six patients per cohort. The DRC will determine RP2D based on tolerability and PK. At Stage 2, 36 patients will be treated at RP2D with an interim analysis after 21 patients have been enrolled. The adaptive design for biomarker-driven patient selection allows for a substantial proportion of the patients treated at the RP2D to have CRPC tumors that express APR.


Glenn Mattes, President and Chief Executive Officer of Arno Therapeutics, said, "The abstracts accepted for poster presentation at this year's ASCO meeting are a testament to the strides we have made to advance our strategic clinical development plan for onapristone. We continue to actively enroll patients in two Phase I trials to evaluate this oral anti-progestin, which has the potential to be a first-in-class compound approved for oncology indications and provide chemotherapy-sparing treatment to cancer patients who express a specific biomarker. We are excited by the momentum generated thus far and look forward to discussing further at the Annual Meeting."

Onapristone is an oral anti-progestin 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 breast, endometrial and other tumors driven by aberrant function of the PR. 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 currently under development.

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 the potential of onapristone as a treatment for breast, prostate and other cancers, 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, 2013. 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
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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