Arno Therapeutics' AR-13 Data Show Promise As Potential New Therapeutic Option For Cystic Fibrosis Patients With Serious Bacterial Infections

FLEMINGTON, N.J., Sept. 24, 2015 (GLOBE NEWSWIRE) -- Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced data from a preclinical study demonstrating AR-13, an analogue of the Company's AR-12 infectious disease compound portfolio, has promise as a potential new therapeutic option for patients with cystic fibrosis (CF) acutely and chronically infected with Burkholderia cenocepacia and other antibiotic resistant organisms such as Pseudomonas aeruginosa.

The dataset will be presented in a poster session during the upcoming 29th Annual North American Cystic Fibrosis (NACF) Conference, being held October 8-10, 2015 in Phoenix, AZ.

Abstract #319 – AR-13 as a potential new therapeutic for reducing Burkholderia Cenocepacia burden in CF macrophages

Poster Session:	Main Poster session
Date, Time:	Thursday, October 8; 11:50 a.m. - 1:50 p.m. MT
	Saturday, October 10, 7:30 a.m. - 8:45 a.m. MT
	Also available as an e-poster
Location:	Hall CDE, Phoenix Convention Center in the main Exhibit Hall

THP-1 monocyte cell line, human peripheral blood samples containing monocyte derived macrophages and neutrophils from patients with CF and blood samples from non-CF healthy controls were used for this preclinical study.

Results demonstrate that AR-13 in combination with broad-spectrum antibiotics has synergistic effects on reducing antibiotic-resistant B. cenocepacia burden in human CF macrophages. AR-13 alone also significantly reduces the CF pathogen Pseudomonas aeruginosa burden in CF neutrophils – specifically, a 70% reduction in P. aeruginosa burden in CF neutrophils and 66% reduction in non-CF neutrophils using AR-13 alone.

Benjamin T. Kopp, MD, Assistant Professor, Department of Pediatrics at The Research Institute at Nationwide Children's Hospital, commented, "The NACFC Annual Meeting offers researchers and physicians a central opportunity to learn about and present new research and discoveries on cystic fibrosis (CF) – one of the most debilitating genetic disorders for children for which there is no cure. These data are promising as they show AR-13 could possibly be used with antibiotics to reduce the antibiotic resistant pathogen burden present in human CF macrophages. Importantly, we found that CF and non-CF macrophages and neutrophils safely tolerated AR-13 in relatively high concentrations, with increased macrophage viability in CF compared to antibiotics alone. We are pleased to present these very compelling and interesting preclinical findings for AR-13."

Alexander Zukiwski, MD, Chief Executive Officer of Arno Therapeutics, added, "AR-13 appears to exhibit unique autophagy induction properties that have benefit in reducing the burden of intracellular pathogens. The reported in vitro activity of AR-13 in macrophages from patients with cystic fibrosis infected with difficult-to-treat bacterial pathogens demonstrates the differential activity of this compound which is based on a common "backbone" of the same chemical series as AR-12. The broad potential for antimicrobial activity of the compound series is further supported by the activity observed against methicillin resistant staphylococcal aureus (MRSA) of the compound series as described in the literature. Although early, we believe this AR-13 data set holds substantial promise in treating antibiotic resistant bacteria in patients with CF. We look forward to evaluating AR-13 further as a potential therapeutic option for B. cenocepacia and P. aeruginosa infections in patients with CF for which there are limited effective treatments due to antibiotic resistance and defective host cells not being able to kill the bacteria."

About AR-13 and AR-12

AR-13 is an analogue of AR-12 and being evaluated as part of the AR-12 infectious disease product portfolio. AR-12 is an orally-available small molecule. Data reported previously demonstrate that the AR-12 mechanism of action may include induction of host cell autophagy and inhibition of a number of protein chaperones. AR-12 has completed Phase 1 clinical trials in patients with cancer. AR-12 has been granted two orphan drug designations in Europe for the treatment of cryptococcosis and tularaemia. In addition, Arno also has the rights to a broad portfolio of compounds in the "AR-12 series", which have been demonstrated to have a broad spectrum antimicrobial activity. In addition, the anti-viral activity of AR-12 and various analogues against Ebola and other pathogens of biodefense interest is being evaluated under a Cooperative Research and Development Agreement (CRADA) Material Transfer Agreement with the US Army Medical Research Institute of Infectious Diseases (USAMRIID).

About Arno Therapeutics

Arno Therapeutics is a clinical stage biopharmaceutical company developing innovative products for the treatment of cancer and other life threatening diseases. Arno has exclusive worldwide rights to develop and market three innovative product candidates. These compounds are in clinical or preclinical development as product candidates to treat hematologic malignancies and solid tumors, as well as infectious diseases. 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 mechanism of action of AR-12, its potential as an anti-viral and antimicrobial agent and to treat other infectious diseases and cancer, the timing, progress and anticipated results of the development of AR-12, as well as Arno's strategy, future operations, outlook, milestones, future financial position, future financial results, plans and objectives. The Company may not actually achieve these plans, intentions or expectations and Arno cautions investors not to place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements made. Various important factors could cause actual results or events to differ materially from the forward-looking statements. Such factors include, among others, risks that the results of further preclinical and clinical trials will not support Arno's claims or beliefs concerning the effectiveness of AR-12 or any other product candidates, the ability to finance the development of AR-12 and other product candidates, regulatory risks, and 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, 2014 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. 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 Lee Roth (investors) lroth@theruthgroup.com (646) 536-7012 Kirsten Thomas (media) kthomas@theruthgroup.com (508) 280-6592

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