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news.The FDA has placed Threshold Pharmaceuticals' development program for TH-070 in benign prostatic hyperplasia on partial clinical hold after abnormalities in liver enzyme levels were observed.
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These abnormalities include three serious adverse events observed at three months of dosing in the phase III European/Canadian clinical trial and three additional observations of elevated liver enzymes that occurred in other ongoing clinical trials.
The FDA has requested that the company provide additional information related to the drug’s acceptable dose and duration of treatment in BPH patients.
Threshold said that it is amending its phase III European/Canadian trial to discontinue dosing. 567 patients have been enrolled in this study, virtually all whom have completed 28 days of dosing. Data from these patients combined with that from the 216 US phase II patients will be evaluated and will inform the company’s next steps for this program and its response to the FDA.
“Our main priority right now is the safety of our patients and we are working with the FDA to resolve these safety issues as quickly as possible,” said Alan Colowick, Threshold’s chief medical officer.