Accrual Under Way

Ohio State Cancer Drug Begins Clinical Testing

Ching Shih ChenA targeted, oral, anticancer drug developed by cancer researchers at The Ohio State University is being tested in a phase I clinical trial to assess its safety and early evidence of activity. The drug, AR-12, has inhibited solid tumors and lymphoma in animal studies.

Patients with advanced or recurrent breast, colon, lung or prostate cancers or lymphoma who have not responded to previous chemotherapy are eligible for the trial, says principal investigator James Thomas, MD, PhD, director of the Clinical Trials Office at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute (OSUCCC – James). Ohio State is one of three sites accepting patients to this trial.

Michael A. Caligiuri, MD, director of the OSUCCC and CEO of The James, says Ohio State researchers worked almost a decade to refine this novel treatment mechanism. “This is a ground-breaking achievement for cancer research at Ohio State because it marks the first time a therapeutic drug developed by our scientists will be tested in cancer patients,” says Caligiuri.

OSUCCC – James researcher Ching-Shih Chen, PhD, worked with cancer and pharmacy colleagues at Ohio State to develop the small-molecule agent, originally called OSU-03012. The agent is being developed as AR-12 by Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics.

“The new agent inhibits PDK-1 and PI3k/Akt pathways, a fundamental signaling point in cancer cells, making AR-12 potentially effective in a wide range of cancer types,” says Chen, a professor of Pharmacy and Internal Medicine.

Chen and colleagues used celecoxib (Celebrex), a nonsteroidal anti-inflammatory drug, to construct AR-12, which triggers cancer cells to self-destruct. In 2004, the agent was accepted by the National Cancer Institute’s Rapid Access to Intervention and Development program, which facilitates the development of promising experimental drugs.

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