Arno Therapeutics, Inc. (ARNI.PK), a clinical-stage biopharmaceutical company focused on developing oncology therapeutics, today announced the dosing of the first patient in an investigator sponsored Phase I/IIa clinical study of AR-42 (formerly OSU-HDAC42) at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) in adult patients with relapsed or refractory multiple myeloma (MM), chronic lymphocytic leukemia (CLL) or lymphoma.
“It is exciting to see this very potent broad class I/IIa HDAC inhibitor enter the clinic for treatment of blood cancers and we look forward to generating meaningful clinical results from this Phase I/IIa study”
The primary objective of this Phase I/IIa, open-label, single-agent dose escalation study is to evaluate the safety and tolerability of oral AR-42 by establishing the maximum tolerated dose (MTD). The secondary objectives include characterizing the pharmacokinetics of the compound, evaluating pharmacodynamic changes in patient biomarkers, and assessing preliminary efficacy of AR-42 in the defined patient population. The Phase I/IIa study is anticipated to enroll up to approximately 50 patients in two phases. The first phase is designed to identify the MTD of the drug, and the second phase will further explore the activity at this MTD dose by enrolling 10 patients into each of three MM, CLL, and lymphoma sub-groups. Craig Hofmeister, M.D., a hematologist and oncologist at OSUCCC-James, is the principal investigator for this single-site clinical trial.
"We are extremely pleased to have enrolled the first patient in the AR-42 Phase I/IIa study. We are very proud of our researchers and clinicians, as this is the second molecule invented at OSUCCC to enter clinical trials within a year. We are encouraged by AR-42's preclinical activity, and we feel that this molecule could have meaningful clinical implications," stated Michael Caligiuri, M.D., director of Ohio State's Comprehensive Cancer Center and chief executive officer of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.
"It is exciting to see this very potent broad class I/IIa HDAC inhibitor enter the clinic for treatment of blood cancers and we look forward to generating meaningful clinical results from this Phase I/IIa study," said John Byrd, M.D., associate director of translational research at the OSUCCC-James and a leukemia specialist.
"The enrollment of the first patient in this Phase I/IIa study of AR-42 is a significant achievement for Arno and OSUCCC-James. We believe that AR-42 is an exciting compound that has exhibited greater potency and preclinical efficacy in multiple preclinical tumor models when compared to other agents in the class. We look forward to continued enrollment and the collection of clinical data," stated Arie Belldegrun, M.D., FACS, Chairman of Arno Therapeutics.
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