|Creating the next generation of cancer treatments
March 17, 2009
FDA Accepts IND for Arno Therapeutics’ Pan-DAC/Akt Inhibitor, AR-42
PARSIPPANY, N.J., March 17, 2009 -- Arno Therapeutics, Inc. (OTC Bulletin Board: ARNI), 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-42.
AR-42 is an orally available, novel, potent, small molecule that modifies the acetylation of histones and other molecules, and is a targeted inhibitor of the Pan-DAC and Akt pathways. HDAC inhibitors disrupt HDAC-PP1 complexes and cause signaling kinase dephosphorylation. In preclinical studies, AR-42 has demonstrated greater potency and a competitive profile in tumors when compared with vorinostat (also known as SAHA and marketed as Zolina ® by Merck), the leading marketed histone deacetylase inhibitor. Arno in-licensed the exclusive worldwide rights to AR-42 from The Ohio State University.
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 pre-clinical compounds. AR-12 is a potential first-in-class, orally available PDK1 inhibitor that blocks the PI3K/Akt pathway undergoing IND-enabling studies. AR-42 is an orally available, targeted inhibitor of the Pan-DAC and Akt pathways.
For more information on Arno please visit www.arnothera.com.
Brian Lenz, CPA
Chief Financial Officer
Arno Therapeutics, Inc.
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.