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October 21, 2015
Arno Therapeutics Demonstrates AR-12 Has Potent Antiviral Activity Against Drug-Resistant HIV Strains
Data from preclinical in vitro study presented today at 15th European AIDS Conference
FLEMINGTON, NJ - October 21, 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 data demonstrating that AR-12 has potent in vitro antiviral activity against HIV-1, HIV-2 and drug-resistant HIV-1. Results were presented today in a poster presentation during the 15th European AIDS Conference, which is hosted by the European AIDS Clinical Society (EACS) and being held October 21-24 in Barcelona, Spain.
Results of the in vitro studies demonstrated that AR-12 inhibits HIV-1, HIV-2 and six drug resistant HIV-1 strains with 50% inhibitory concentrations (IC50) in the range of 240-1016 nM (nanomolar) and moderate cytotoxicity (5532 nM). The IC50s were found in this study to be consistent with the IC50s observed against other viral pathogens including Influenza A, Chikungunya, Ebola, Lassa and others.
Previous studies have demonstrated AR-12 down regulates the host cell chaperone machinery, including GRP78, HSP70, HSP90 and HSP27. GRP78 is a critical chaperone protein, whose inhibition results in the up-regulation of PERK, inducing autophagy and facilitating the clearing of intracellular viruses and/or phagocytized unfolded proteins. Interfering with the host chaperone proteins in cells infected with viruses is thought to prevent the proper folding of viral proteins and efficient viral assembly.
These findings suggest that AR-12 inhibits HIV through a mechanism of action different from other inhibitors currently on the market, encompassing the major classes of HIV drugs currently available. These preclinical investigations confirmed that host cell targeting by AR-12 may be an effective approach to inhibit the replication of HIV at low concentrations that can be achieved in the clinical setting with an oral tablet formulation.
Findings from the study, titled "AR-12, a Novel First in Class Host Cell Targeting Therapeutic Candidate with Potent Activity Against HIV Multidrug Resistant Strains in vitro" (Poster PE6/4; Abstract #1094), will be presented by Arno Chief Development Officer Stefan Proniuk, Ph.D. during a Poster Session at the conference starting on Thursday, October 22 at 12:00 p.m. CEST.
Stefan Proniuk, Ph.D., Chief Development Officer of Arno Therapeutics, commented, "These findings indicate that AR-12's novel antiviral mechanism of action offers a new promising approach to potentially circumvent existing resistance mechanisms, enhance existing HIV treatments through combination therapies and to potentially address co-infections with other viral pathogens. The results demonstrated in these in vitro studies in HIV strains are consistent with the broad spectrum antiviral activity findings we have shown in other viruses, including Ebola, Nipah, Lassa, Marburg, Junin, Tacaribe, Yellow Fever, Hepatitis C, Epstein Barr, Venezuelan equine encephalitis, Chikungunya and Influenza (H1N1, H3N2), which collectively provide insight into the depth of AR-12's anti-viral capabilities."
Alexander Zukiwski, M.D., Chief Executive Officer of Arno Therapeutics, added, "We are pleased with the findings from these in vitro studies which further support AR-12 as a potential versatile and effective antiviral compound. Based on these results, we plan to initiate a SAD/MAD study to assess the safety of single dose and multiple doses of a new optimized formulation of 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 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.
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