Arno Therapeutics to commence Phase 1 clinical study of AR-12 in adult patients with lymphoma

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).

“I am very enthusiastic about this Phase I study with AR-12, a compound that may play a role in a number of crucial pathways in cancer cells. We hope that AR-12’s effects in cancer patients will match its unique preclinical activity as an inhibitor of PDK-1, which has recently been identified as an important target in cancer cells,” stated Dr. Johann de Bono, the principal investigator at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, in the United Kingdom.

“The enrollment of our first patient in our Phase I study of AR-12 is a significant milestone for Arno. AR-12 is an exciting compound that has shown activity in the laboratory across a broad range of solid and hematologic malignancies, both as a single agent and in combination with other approved targeted therapies. We look forward to generating confirmatory clinical data,” stated David Tanen, President of Arno.