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.