The study was conducted at The Ohio State University Comprehensive Cancer Center, Arthur James Cancer Hospital and Richard Solove Research Institute (OSUCCC-James).
Arno said that 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 ascertaining the maximum tolerated dose (MTD).
The secondary objectives include characterising the pharmacokinetics of the compound, assessing pharmacodynamic changes in patient biomarkers, and evaluating preliminary efficacy of AR-42 in the defined patient population.
The Phase I/IIa study is expected to recruit up to approximately 50 patients in two phases. The first phase is designed to identify the MTD of the drug, and the second phase is expected to further explore the activity at this MTD dose by recruiting 10 patients into each of three MM, CLL, and lymphoma sub-groups.
Michael Caligiuri, director of comprehensive cancer center at Ohio State and CEO of the Arthur James Cancer Hospital and Richard Solove Research Institute, said: “We are extremely pleased to have recruited the first patient in the AR-42 Phase I/IIa study.
“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.”
John Byrd, associate director of translational research at the OSUCCC-James and a leukemia specialist, said: “It is exciting to see this 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.”
Arie Belldegrun, chairman of Arno , said: “The recruitment of the first patient in this Phase I/IIa study of AR-42 is an achievement for Arno and OSUCCC-James. We look forward to continued enrollment and the collection of clinical data.”