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Arno Therapeutics Data Demonstrate AR-12 as Novel Antifungal Drug Against Common Finger and Toenail Fungus, Onychomycosis

FLEMINGTON N.J., Oct. 29, 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 demonstrating that AR-12 is a promising novel antifungal agent for the treatment of onychomycosis, a common fungal infection of the fingernails and toenails, with activity against two primary fungal organisms responsible for causing the condition. Results will be presented in a poster presentation, titled "Trans-ungual Delivery of AR-12, a Novel Antifungal Drug" (Poster R6046), on Thursday, October 29 during the 2015 American Association of Pharmaceutical Scientists Annual Meeting and Exposition, being held in Orlando, FL.

Stefan Proniuk, Ph.D., Chief Development Officer of Arno Therapeutics, commented, "Onychomycosis is an infection that leads to thickened, discolored and split nails and that has increasing prevalence in the U.S. – currently affecting approximately 10% of the general population1 and resulting in a growing need for more effective drugs for improving the success rate and decreasing the required duration of topical therapy. The effectiveness of current topical therapies on the market may in part be limited due to the poor permeability of the nail plate to topically-applied therapeutic agents. AR-12 has been found to penetrate the nail bed and to be highly potent against Trichophyton rubrum fungus which is predominantly responsible for causing onychomycosis. While early, these findings indicate that AR-12 may have substantial clinical potential as a new drug candidate for treating onychomycosis as a result of its ability to penetrate across the nail plate. The results of this study provide a strong rationale for further development. Furthermore, we are pleased that AR-12 has demonstrated its potential versatility in yet another infectious disease."

Findings, from a team of various collaborators, demonstrated that AR-12 is able to penetrate across the human nail plate in significant amounts, which can be further improved with the use of identified permeation enhancers. The study found that the amount of AR-12 permeated across the human nail plate after one week was 0.82±0.11 ng/cm2, and the amount of drug retained in active diffusion area of the nail plate was ~0.42±0.02 µg/mg.

In addition, the study demonstrated that two common permeation enhancers, PEG-400 (polyethylene glycol 400, a low-molecular-weight grade) and dexpanthenol, have the potential to powerfully enhance the trans-ungual delivery of AR-12. In vitro permeation studies showed the amount of AR-12 permeated across the nail plate after application of combination formulation containing dexpanthenol and PEG 400 was found to be ~5.6 and 5.2 fold more than control. The combination of both enhancers together did not lead to any additive or synergistic enhancement in permeation of AR-12. The amount of AR-12 retained in the nail plate in formulations containing dexpanthenol and PEG 400 was found to be ~1.6 and 1.7 fold more relative to control. The amount of AR-12 in the peripheral nail plate was enhanced by 3.0 and 3.7 folds respectively. The combination enhanced the retention up to 2.1 and 3.4 folds more than control in the active diffusion area and peripheral region on the nail plate.

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 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.

1 Kushwaha, A.S., Sharma, P., Rappleye, C., Zukiwski, A., Proniuk, S., Narasimha-Murthy, S. (2015) Trans-Ungual Delivery of AR-12, a Novel Antifungal Drug, S.N. Murthy Research Group

CONTACT: The Ruth Group Lee Roth (investors) lroth@theruthgroup.com (646) 536-7012 Kirsten Thomas (media) kthomas@theruthgroup.com (508) 280-6592

Source:Arno Therapeutics Inc.