|Creating the next generation of cancer treatments
August 27, 2009
Arno Therapeutics Announces Dosing of First Patient in Phase I of AR-12, a PDK-1 Inhibitor Targeting the PI3K/Akt Pathway
PARSIPPANY, N.J., August 27, 2009 -- Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced the dosing of the first patient in a Phase I clinical study of AR-12 (formerly OSU-03012) in adult patients with advanced or recurrent solid tumors or lymphoma.
The primary objective of this Phase I, open-label, single-agent dose escalation study is to evaluate the safety and tolerability of AR-12 by establishing the maximum tolerated dose. The secondary objectives include evaluating the pharmacokinetics of the compound as well as utilizing biomarkers and preliminary anti-tumor activity to characterize the biologically active dose range of AR-12. The Phase I study is planned to enroll up to a total of 50 patients at sites in both the United States and United Kingdom. Patients will receive AR-12 orally for 28 consecutive days with a 7 day break between the first and second treatment cycles.
"We are very pleased to enroll the first patient in the AR-12 Phase I study at The Ohio State University. We feel that this is a momentous achievement for both Arno and our institution, as this is the first molecule invented at The Ohio State University to enter clinical trials. We are encouraged by AR-12's preclinical activity in a wide range of tumor types and feel that this molecule could have exciting clinical implications," stated James Thomas, M.D, Ph.D, the principal investigator at The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute (OSUCCC-James).
"I am very enthusiastic about this Phase I study with AR-12, a compound that may play a role in a number of crucial pathways in cancer cells. We hope that AR-12's effects in cancer patients will match its unique preclinical activity as an inhibitor of PDK-1, which has recently been identified as an important target in cancer cells," stated Dr. Johann de Bono, the principal investigator at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, in the United Kingdom.
"The enrollment of our first patient in our Phase I study of AR-12 is a significant milestone for Arno. AR-12 is an exciting compound that has shown activity in the laboratory across a broad range of solid and hematologic malignancies, both as a single agent and in combination with other approved targeted therapies. We look forward to generating confirmatory clinical data," stated David Tanen, President of Arno.
AR-12 is potentially a first-in-class, orally available, PDK-1 inhibitor that targets the PI3-K/Akt ocogenic pathway and also induces autophagy and the endoplasmic reticulum mediated apoptosis stress pathway. Preclinical data have demonstrated that AR-12 is active in a wide range of tumor types and shows promising activity in combination with several widely used anti-cancer agents, including Avastin®, Herceptin®, Gleevec®, Tarceva®, Nexavar® and tamoxifen.
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-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 has begun a Phase II study in patients with Myelodysplastic Syndrome (MDS) who have failed prior therapies. MDS is a group of pre-malignant blood disorders marked by abnormal production of blood cells by the bone marrow. A separate AR-67 Phase II study is planned for initiation during 2009 in glioblastoma multiforme (GBM), a highly aggressive form of brain cancer.
Arno is developing two additional drug candidates. The first, AR-12, is a potential first-in-class, orally available PDK1 inhibitor that blocks the PI3K/Akt pathway and also induces autophagy and the endoplasmic reticulum stress pathway. The other, AR-42, is an orally available, targeted Pan-HDAC inhibitor for which Arno had an IND accepted by the FDA in the first quarter of 2009.
For more information on Arno please visit www.arnothera.com
About The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute
The Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute is one of only 40 Comprehensive Cancer Centers in the United States designated by the National Cancer Institute. Ranked by U.S. News & World Report among the top 20 cancer hospitals in the nation, The James is the 180-bed adult patient-care component of the cancer program at The Ohio State University. The OSUCCC-James is one of only five centers in the country approved by the NCI to conduct both Phase I and Phase II clinical trials.
For more information on The Ohio State University please visit: www.jamesline.com
About The Institute of Cancer Research
The Institute of Cancer Research (ICR) is Europe's leading cancer research centre with expert scientists working on cutting-edge research. In 2009, the ICR marks its 100 years of groundbreaking research into cancer prevention, diagnosis and treatment. The ICR is home to the world's leading academic drug development team, which has developed many drugs now used as standard cancer treatments. It continues to be at the forefront of drug development, discovering an average of two preclinical candidates each year over the past five years. In December 2008, the ICR was ranked as the UK's leading academic research centre by the Times Higher Education's Table of Excellence, based on the results of the Higher Education Funding Council's Research Assessment Exercise. The ICR is a charity that relies on voluntary income. It is one of the world's most cost-effective major cancer research organisations with more than 95p in every £ directly supporting research.
For more information on ICR please visit: www.icr.ac.uk
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 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.