FDA Accepts Arno Therapeutics' IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway

PARSIPPANY, N.J., May 11 /PRNewswire-FirstCall/ -- Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced that the U.S. Food and Drug Administration ("FDA") accepted the Company's Investigational New Drug ("IND") application for the use of AR-12, a potentially first-in-class, orally available, PDK1 inhibitor that blocks the PI3K/Akt pathway and induces the endoplasmic reticulum stress pathway. Acceptance of the IND permits Arno to initiate a Phase I clinical trial in adults with advanced or recurrent solid tumors or lymphoma for which no standard therapy is available. Arno expects the Phase I clinical trial to begin during the second half of 2009 and will be designed to assess the safety and early evidence of activity of AR-12.

"We are excited that AR-12 has received IND acceptance by the FDA allowing us to begin our Phase I studies. Our preclinical data has demonstrated that AR-12 is active in a wide range of tumor types and it also shows promising activity in combination with several widely used approved cytotoxic as well as molecularly targeted anti-cancer agents," stated Dr. Roger G. Berlin, Chief Executive Officer of Arno.

About AR-12

AR-12 is a potentially first-in-class, orally available, PDK1 inhibitor that blocks the PI3K/Akt pathway and induces the endoplasmic reticulum stress pathway.

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 development compound is AR-67, a novel, third-generation camptothecin analogue which has completed patient enrollment of its Phase I studies in patients with advanced solid tumors, that has demonstrated high preclinical potency and improved pharmacokinetic properties when compared with marketed second-generation products in its class. Arno is also developing two additional drug candidates. AR-12 is a potential first-in-class, orally available PDK1 inhibitor that blocks the PI3K/Akt pathway and induces the endoplasmic reticulum stress pathway, that received FDA acceptance of its IND in the second quarter of 2009. AR-42, an orally available, targeted inhibitor of the Pan-DAC and Akt pathways received FDA acceptance of its IND in the first quarter of 2009.

For more information on Arno please visit www.arnothera.com.

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 that 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.

SOURCE Arno Therapeutics, Inc.



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