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).