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Arno Therapeutics Announces Preclinical Data Demonstrating Broad-Spectrum Antiviral Activity for AR-12

FLEMINGTON, N.J., May 14, 2015 (GLOBE NEWSWIRE) -- Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for the treatment of cancer and other life threatening diseases, today announced data supporting the development of AR-12 as a broad-spectrum, host-directed antiviral drug. Results of the preclinical studies were presented today at the 28th Annual International Conference on Antiviral Research (ICAR), hosted by the International Society for Antiviral Research (ISAR) and being held May 11 – 15, 2015 in Rome, Italy.

Results from the studies evaluating AR-12, a novel orally-available small molecule, demonstrate the compound's potent antiviral activity in the 0.3-1.2 micromolar (µM) range against several viruses, including Influenza A, Tacaribe virus and the hemorrhagic fever viruses including Ebola, Lassa, Marburg, Nipah and Junin. The data outline that the antiviral activity of AR-12 is believed to be based on host-cell target modulation, with AR-12 having the ability to down regulate and inhibit critical chaperone proteins GRP78, HSP70 and HSP90. The utilization of, or "highjacking", of these host chaperone proteins is critical for viable viral replication and assembly. The ability of AR-12 to inhibit these chaperone proteins is believed to contribute to its broad-spectrum antiviral activity and its potential ability to circumvent certain antiviral drug resistance mechanisms.

Findings from the study, titled "AR-12: A Novel Broad-spectrum Host-directed Antiviral Drug" (Abstract # 218), were presented by Arno Chief Development Officer Stefan Proniuk, Ph.D. during Poster session 2 on Thursday, May 14 from 4:00-6:00 pm CET.

Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics, commented, "On the heels of receiving European orphan drug designation for AR-12 in two infectious diseases earlier this month, we look forward to sharing encouraging results from a series of preclinical studies evaluating the broad spectrum antiviral activity of AR-12. Overall, the studies demonstrate the unique ability of AR-12 to inhibit key host chaperone proteins and potentially circumvent certain antiviral drug resistance mechanisms. Furthermore, established safety from an Investigational New Drug (IND)-enabling toxicology program and a previous Phase I study position the compound for potentially rapid development as an antimicrobial agent. We will continue to evaluate AR-12 in in-vivo studies to confirm its activity and profile as the lead compound of a potentially new class of antimicrobial drugs."

The precise antiviral mechanism of action of AR-12 continues to be evaluated but an established body of evidence demonstrates that AR-12 is an inducer of host effector cell autophagy. AR-12 is known to inhibit, or down regulate, GRP78 (also known as BiP, HSPA5) the master regulator of the unfolded protein response. The down regulation of GRP78 results in the up-regulation of PERK which induces the formation of autophagosomes and, subsequently, host cell autophagy. AR-12 also down regulates the chaperone proteins HSP70 and HSP90.

About AR-12

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 fungal acetyl coenzyme A synthetase. Previously, AR-12 has completed Phase 1 clinical trials in patients with cancer. Additional pre-clinical research indicates that AR-12 may have potential as an antimicrobial agent in various infectious diseases. 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.

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 other life threatening 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 potential of AR-12 as a potential therapy as an anti-viral and antimicrobial agent and for 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. 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 (646) 536-7014 Arno Therapeutics Lawrence Kenyon lk@arnothera.com (862) 703-7171

Source:Arno Therapeutics Inc.