|Creating the next generation of cancer treatments
July 23, 2009
Arno Therapeutics Announces Enrollment of First Patient in Phase II Study of AR-67 (formerly DB-67) in Patients with Myelodysplastic Syndrome
PARSIPPANY, N.J., July 23, 2009 -- Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced the dosing of the first patient in a Phase II clinical study of AR-67 in adult 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.
The Phase II, open-label, single-arm study is designed to evaluate the efficacy of AR- 67, dosed intravenously for five days over four cycles or approximately 16 weeks. Up to 25 patients are expected to be enrolled in this clinical trial, which is being conducted at the University of Texas, M.D. Anderson Cancer Center (MDACC), in Houston, Texas. The primary objective of the Phase II study is to determine the response rate of AR-67 in patients with MDS. Secondary objectives include evaluation of the safety, response duration and disease-free survival of patients with MDS treated with AR-67.
“We are excited about the enrollment of the first patient at MDACC in this study of AR-67 for patients with MDS who have failed prior hypomethylating agents. Topoisomerase I inhibitors have previously shown clinical activity in this disease, and the improved stability of the active lactone metabolite of AR-67, I believe offers the opportunity for AR-67 to fill this unmet medical need in the treatment of MDS,” stated Principal Investigator, Dr. Jorge Cortes, Professor of Medicine and Deputy Chair in the Department of Leukemia, Division of Cancer Medicine at MDACC.
“Based upon the encouraging clinical activity, safety profile and pharmacokinetic characteristics observed in the Phase I trial of AR-67, we are pleased to advance AR- 67 into this Phase II trial in MDS, which represents a significant milestone for Arno,” stated Dr. Arie Belldegrun, Chairman of the Board of Directors of Arno Therapeutics.
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 such as increased stability of the active lactone form of AR-67 in blood when compared to approved second-generation products Hycamtin® (Topotecan) and Camptosar® (Irinotecan). Arno has completed a Phase I single agent, clinical study of AR-67 in patients with advanced solid tumors. A separate Phase II study is planned for initiation during 2009 in glioblastoma multiforme (GBM), a highly aggressive form of brain cancer.
About Arno Therapeutics
Arno Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops and commercializes innovative products for the treatment of cancer patients. In addition to AR-67, 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 induces autophagy and the endoplasmic reticulum stress pathway. Arno’s investigational new drug application (IND) for AR-12 was accepted by the FDA in the second quarter of 2009. 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.
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 forwardlooking 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.