Threshold Pharmaceuticals has announced that the FDA has halted a late-stage clinical trial of its prostate drug because of liver complications found in several participants. The drug, called TH-070, was being tested for its effectiveness against benign prostatic hyperplasia, a non-cancerous condition that causes the prostate gland to swell and begin to eventually block the urethra.
The clinical trial of TH-070 will remain on "partial clinical hold," as the FDA has requested more information on the drug. The company said abnormalities were observed in liver enzyme levels in three serious adverse events.
Threshold said it will discontinue dosing of the 567 patients involved in the trial in Europe and Canada. Nearly all of them have completed 28 days of dosing.