New Prostate Cancer Drug Showing Promise in Clinical Trials

For immediate release: September 07, 2014

Developed in UM Greenebaum Cancer Center labs, compound could address unmet need for treatment of advanced disease

A compound discovered by University of Maryland Marlene and Stewart Greenebaum Cancer Center researchers Angela Brodie, PhD, and Vincent Njar, PhD, is showing promise in clinical trials for treatment of castration-resistant prostate cancer (CRPC), the most advanced state of the disease. The drug, called galeterone, cuts off the supply of androgens, which are male sex hormones that make prostate cancer grow and spread.

The drug has been licensed by the University of Maryland to Tokai Pharmaceuticals, Inc., which is testing galeterone through its ARMOR clinical trial program. Interim data from an ongoing two-part Phase 2 clinical trial show that patients had meaningful reductions in levels of prostate-specific androgen, or PSA.

The drug uses a novel three-pronged approach to cut off the supply of androgens. Prostate cancer treatments currently on the market either limit the production of androgens or block their action, and approximately 50 percent of prostate cancer patients have tumor recurrence after five years because they have developed resistance to these treatments. Galeterone combines these two approaches and adds a third – degrading the amount of the receptor. With these mechanisms of action, galeterone may lessen patients' risk of developing resistance and improve their survival.

In 2012, the drug received Fast Track designation from the U.S. Food and Drug Administration, allowing for expedited development and review processes to help bring it to market as quickly as possible. Phase 2 clinical trials are continuing throughout 2014.