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March 24, 2015

New Data Supporting Arno Therapeutics' HDAC inhibitor AR-42 Published in The Journal of Urology

Demonstrate Synergetic Anti-tumor Effects of AR-42 with Cisplatin in Bladder Cancer Models

FLEMINGTON, NJ - March 24, 2015 - Arno Therapeutics, Inc. (OTCQB: ARNI), a clinical stage biopharmaceutical company primarily focused on the development of oncology therapeutics, today announced that data from a preclinical study demonstrate its histone-deacetylase (HDAC) inhibitor AR-42 in combination with cisplatin has a synergistic anti-tumor effect in bladder cancer models. These data were recently published online ahead of print in The Journal of Urology.

AR-42 is a novel oral, broad-spectrum agent therapy currently in early clinical development. As a deacetylase inhibitor of both histone and non-histone proteins, AR-42 has demonstrated greater potency and activity in solid tumors and hematological malignancies when compared in preclinical studies to vorinostat (also known as "SAHA" and marketed as Zolinza® by Merck), the first of four marketed compounds in the class. AR-42 may possess additional histone-independent mechanisms, which may contribute to its superior profile in vitro and in vivo.

The study, led by Arnold I. Chin, MD, PhD, Assistant Professor, Department of Urology at University of California, Los Angeles (UCLA) Jonsson Comprehensive Cancer Center (JCCC), demonstrates the ability of AR-42 to synergize with cisplatin to augment the destruction of bladder cancer cells in vitro and in vivo, and to preferentially target the bladder cancer stem cell population.1 Specifically, the research shows that the combination of AR-42 and cisplatin synergistically kills bladder cancer cells through apoptosis and influences tumor growth and differentiation in vivo.1 This synergistic effect may also improve the efficacy and overall response rate of cisplatin, and allow for a lower dosage, resulting in potentially lower toxicities in patients.1 Furthermore, when tested on specific bladder cancer stem cell populations (marked by surface markers CD44+ and CD49f+), AR-42 showed greater efficacy, with and without cisplatin.1

Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics, commented, "These results are encouraging and, although early, establish preclinical evidence that AR-42 may have potential in conjunction with cisplatin-based chemotherapy in the treatment of bladder cancer. Overall, the findings support further clinical investigation of AR-42 in this indication. We are grateful to lead author Dr. Arnold Chin and his team at UCLA for their research and look forward to additional collaboration as we continue to explore this novel therapy."

Bladder cancer affects more than 54,000 men and 17,000 women in the United States annually, making it the fourth most common cancer among men and ninth most common cancer in women.2 Bladder cancer treatments have remained unchanged for decades and continue to be mainly composed of cisplatin-based chemotherapy regimens that have limited response rates and efficacy. Research has shown that molecular analysis of bladder cancer reveals a high incidence of mutations in chromatin regulatory genes, suggesting a therapeutic avenue for HDAC inhibitors.1

About AR-42

AR-42 is a novel oral agent therapy currently in early clinical development. It is a broad-spectrum deacetylase inhibitor of both histone and non-histone proteins, which has demonstrated greater potency and activity in solid tumors and hematological malignancies when compared in preclinical studies to vorinostat (also known as "SAHA” or Zolinza), the first of four marketed compounds in the class. AR-42 may possess additional histone-independent mechanisms, which may contribute to its superior profile in vitro and in vivo. It has been designated an orphan drug by the FDA for the treatment of meningioma and schwannoma of the central nervous system. Meningioma and schwannoma are rare, benign tumors that can present in different locations within the brain and the spinal cord and may cause substantial morbidity.

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 anti-cancer product candidates. These compounds are in clinical or preclinical development as product candidates to treat hematologic malignancies and solid tumors. For more information about the company, please visit

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-42 as a potential therapy for bladder cancer, the timing, progress and anticipated results of the development of AR-42, as well as Arno's strategy, future operations, outlook, milestones, future financial position, future financial results, plans and objectives. We may not actually achieve these plans, intentions or expectations and Arno cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make. Such factors include, among others, risks that the results of further preclinical and clinical trials will not support our claims or beliefs concerning the effectiveness of AR-42 or any of our other product candidates, our ability to finance the development of AR-42 and our other product candidates, regulatory risks, and our 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, 2013 and its Quarterly Report for the quarter ended September 30, 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.


1 Li D.R., Zhang H., Peek E., Wang S., Du L., Li G., Chin A.I. Synergy of histone-deacetylase inhibitor AR-42 with cisplatin in bladder cancer. J. Urology. 2015.

2 Siegel R, Naishadham D and Jemal A: Cancer statistics, 2013. CA. Cancer J. Clin. 2013; 63: 11-30.


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