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September 19, 2015
Arno Therapeutics Data Demonstrates Novel Antimicrobial Activity of AR-12, Identified it as Lead Compound of New Class of Drugs
Podium Presentation and Data Posters Presented at ICAAC/ICC 2015 on Saturday, Sept. 19
FLEMINGTON, NJ - September 19, 2015 - 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 promising data demonstrating novel activity of AR-12 as a broad-spectrum, anti-microbial drug. Results were presented over the weekend in a podium presentation and in posters at ICAAC/ICC 2015 (Interscience Conference of Antimicrobial Agents and Chemotherapy / International Congress of Chemotherapy and Infection), which is jointly hosted by the American Society for Microbiology (ASM) and International Society of Chemotherapy (ISC) and took place September 17-21 in San Diego, CA.
Stefan Proniuk, PhD, Chief Development Officer of Arno Therapeutics, who presented an in vitro inhibition of chikungunya virus replication by AR-12 in a podium presentation on Saturday, September 19, commented, “Prior AR-12 antiviral investigations demonstrate potent activity across a wide range of distinct pathogenic viruses such asInfluenza A, Epstein Barr virus, and hemorrhagic fever virusesincluding Ebola, Marburg, Nipah, Lasa, Junin, Yellow fever. In the two studies we presented at ICAAC/ICC, we now show that AR-12 has a first-in-class, novel mechanism of action that enables its potential for broadspectrum antimicrobial activity, providing additional rationale for the continued development of the compound against a number of infectious disease targets.”
Conclusions from the two Arno presentations on AR-12 are as follows:
Presenting Author: Stefan Proniuk, PhD
Poster Session: Current Research on Respiratory and Other Viruses
Date, Time: Saturday, September 19; 10:30 AM – 10:45 AM PT
Results from a preclinical study assessing broad-spectrum antiviral activity of AR-12 demonstrate that the drug’s first-in-class, novel mechanism of action has the potential for a broad-spectrum antiviral activity including the Chikungunya virus and has the potential to be used in combination with existing antiviral agents which may reduce the emergence of treatment resistant viral pathogens.
Activity of AR-12 was evaluated against the wild-type and T-705 resistant chikungunya virus strains as a model. AR-12’s mechanism of action was shown to down-regulate a number of protein chaperones thus targeting the unfolded protein response. Results indicate that the combination of AR-12 with T-705 resulted in an additive antiviral effect against either the wild-type or T-705- resistant strain of chikungunya. In addition, IND-enabling toxicology studies demonstrated a remarkable preclinical safety profile and a Phase I clinical study (maximum of 33 week exposure) demonstrated that high blood levels can be achieved.
Presenting Author: Stefan Proniuk, PhD
Poster Session: New Anti-Fungal Agents
Date, Time: Saturday, September 19; 11:00 AM – 1:00 PM PT
Results from a preclinical study identify AR-12 as the lead compound of a new class of antifungal agents with a novel mechanism of action.
In vitro cell culture studies were conducted against a broad range of fungi in mice in order to establish the antifungal spectrum of AR-12. The study established that AR-12 inhibited the growth of multiple fungal species at concentrations that have been in the previous phase 1 study. AR-12 exhibited activity against several fungi: Paecilomyces variotii, Rhizopus oryzae, Fusarium oxysporum/solani, Scedosporium apiospermum, Lomentospora prolificans, Apophysomyces, Coccidioides immitis/posadasii, Blastomyces dermatitidis and Pneumocystis carinii/murina.
In addition, AR-12 combined with fluconazole was found to yield a fungicidal cocktail that has improved in-vivo activity against Cryptococcus neoformans compared to either agent alone. The broad spectrum in vitro activity was demonstrated against multiple fungi species tested at a concentration range previous found to be achievable. Overall, the study demonstrated the novel antifungal in vitro mechanism of action of AR-12, broad antifungal in vitro activity as a single agent or in combination with fluconazole, and its established safety profile from a previous clinical study with up to 33 week dosing holds promise for a potential new agent to treat fungal infections.
In addition, two preclinical studies were also presented at ICAAC/ICC 2015 by investigators from the Ohio State University. The first poster (Poster F-760) demonstrated AR-12’s promise as a new antifungal agent for the treatment of mycoses caused by both opportunistic and primary fungal pathogens. The second poster (Poster B-083) showed an encapsulated form of AR-12, in combination with suboptimal gentamicin treatment, further enhanced survival of mice infected with the bacterium Francisella tularenesis, which is the causative agent of the life-threatening disease tularemia, a disease for which AR-12 was recently granted orphan designation in Europe.
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 forwardlooking 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 forwardlooking 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.
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