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Arno Therapeutics Announces Poster Presentation at ASH Annual Meeting Demonstrating Anti-Leukemic Stem Cell Activity of AR-42

PARSIPPANY, N.J.--(BUSINESS WIRE)--Dec 15, 2009 - Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced the presentation of a poster at the annual American Society of Hematology (ASH) meeting that describes the preclinical activity of Arno's drug candidate AR-42 against leukemia stem cells (LSCs). AR-42 is a broad spectrum inhibitor of both histone and non-histone deacetylation proteins that demonstrated potent activity against Acute Myeloid Leukemia (AML) stem cells. The poster, entitled “Identification of the Histone Deacetylase Inhibitor (HDACi), AR-42, as a Novel Anti-Leukemia Stem Cell Agent in Acute Myeloid Leukemia (AML)” was presented at the 51st ASH Annual Meeting and Exposition held December 5-8, 2009 in New Orleans, LA.

LSCs are believed to be able to initiate and perpetuate AML while displaying resistance to standard chemotherapies. The ability to target these cells with therapeutic compounds may help improve patient outcomes. The poster's findings show that AR-42 preferentially targets LSCs compared to normal healthy cells. The research also suggests that AR-42 is active through a mechanism that differentiates it from other compounds with preclinical anti-LSC activity.

“The ability to target cancer stem cells presents an opportunity to change the way that we treat patients, particularly those stricken with diseases that are currently difficult to cure,” stated Monica Guzman, Ph.D., a co-author of the poster with AR-42 at Weill Cornell Medical College. “Patients with AML are prone to recurrent disease, even if therapies are initially effective. Current evidence suggests that the survival of LSCs after treatment may ultimately contribute to the persistence of this disease and its poor clinical prognosis. Inhibiting LSCs may help treat and prevent recurrence of AML in patients.”

“We identified AR-42 by screening a large number of gene expression profiles from the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO) for potential anti-LSC agents. We were very excited to see our hypothesis confirmed both in vivo and in vitro, and we look forward to discovering if the same promising activity will be seen in the clinical setting,” said co-author Duane Hassane, Ph.D. of Weill Cornell Medical College.

“Arno is very excited about the results from these recent studies and feels that this data helps to support our belief that AR-42 has the potential to emerge as a meaningful addition to the landscape of cancer therapies,” stated David Tanen, President of Arno.

About AR-42

AR-42 (formerly known as “HDAC-42”) is an orally available, broad spectrum inhibitor of both histone and non-histone deacetylation proteins (“pan-DAC”), which may both be important in cancer progression. Histone deacetylase (“HDAC”) inhibitors are a growing class of compounds that target histone deactylase, a molecule involved in determining which genes are expressed in a particular cell. In preclinical studies, AR-42 has shown activity against a broad spectrum of deacetylation targets and increased potency compared to vorinostat (“SAHA,” or Zolinza®), the first HDAC inhibitor to obtain FDA approval. Arno currently plans to commence an investigator-initiated Phase I/IIa study with AR-42 in collaboration with an academic institution in the first half of 2010.

About Arno Therapeutics

Arno Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops and commercializes innovative products for the treatment of cancer patients. Arno's lead clinical compound, AR-12 (formerly known as “OSU-03012”), is a potentially first-in-class, orally available, targeted anti-cancer agent that inhibits PDK-1, a protein in the PI3K/Akt pathway, and also causes cell death through the induction of endoplasmic reticulum stress. Arno is developing two additional drug candidates, AR-67 and AR-42. AR-67 is a novel, third-generation camptothecin analogue that inhibits topoisomerase I activity. AR-67 has demonstrated activity and an excellent safety profile in clinical studies as well as improved pharmacokinetic properties when compared to approved second-generation products Hycamtin® (topotecan) and Camptosar® (irinotecan). Arno is conducting a Phase II study of AR-67 in patients with Myelodysplastic Syndrome (MDS) who have failed prior therapies and anticipates commencing a Phase II study in patients with glioblastoma multiforme (GBM), a highly aggressive form of brain cancer by the end of this year.

For more information on Arno please visit

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding the timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings, as well as our strategy, future operations, outlook, milestones, the success of Arno's product development, future financial position, future financial results, plans and objectives of management, are forward-looking statements. 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 clinical trials will not support our claims or beliefs concerning the effectiveness of our product candidates, our ability to finance the development of our product candidates, regulatory risks, and our reliance on third party researchers and other collaborators. Arno is providing this information as of the date of this presentation and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.


Contact: Arno Therapeutics, Inc.
Brian Lenz, CPA, 862-703-7175
Chief Financial Officer


Posted: December 2009