Put to the Test

Second Ohio State cancer drug enters clinical trial

For the second time within 2½ years, an experimental drug created by cancer researchers at the OSUCCC – James is being tested in a clinical trial.

Last summer, adult patients began receiving oral doses of AR-42, which is in a new class of drugs called histone deacetylase (HDAC) inhibitors, or compounds designed to reactivate genes that normally guard against cancer but are turned off by the cancer process.

AR-42 is designed to treat relapsed or treatment-resistant multiple myeloma, chronic lymphocytic leukemia or lymphoma. John C. Byrd, MD, initiated the drug’s development with Ching-Shih Chen, PhD, a cancer researcher and professor of Medicinal Chemistry in the College of Pharmacy.

The phase I/IIa clinical trial is assessing the safety and initial evidence of anticancer activity of the drug. Byrd says Ohio State is the only site worldwide accepting patients to this trial.

“Early tests in cancer cell models showed that AR-42 is 10,000-fold more potent than the starting/parent agent,” says Chen.

In 2003, Byrd asked Chen to try to improve the potency of a short-chain fatty acid known to have a weak inhibitory effect against cancer growth. Chen worked with cancer center and pharmacy colleagues to develop the drug, originally called OSU-HDAC42, a broad spectrum histone and non-histone deacetylation inhibitor (pan-DAC).

The agent has been licensed to the biopharmaceutical company Arno Therapeutics, Inc., for clinical development.

“It is exciting to see this very potent broad-class I/II HDAC inhibitor enter the clinic for treatment of blood cancers, and we look forward to meaningful results,” Byrd says, noting that Craig Hofmeister, MD, is principal investigator on the clinical trial.

In August 2009, the OSUCCC – James began enrolling patients in a clinical trial for AR-12, another anticancer agent designed by Chen’s lab that also is being developed by Arno Therapeutics. AR-12 inhibits solid-tumor
growth by triggering cancer cells to self-destruct.

Byrd is professor of Internal Medicine and the D. Warren Brown Designated Professorship in Leukemia Research. Chen holds the Lucius A. Wing Chair of Cancer Research & Therapy, and is professor of Medicinal Chemistry, of Internal Medicine, and of Urology.

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