FDA places TKM-Ebola trial on clinical hold

|By:, SA News Editor

The FDA notifies Tekmira Pharmaceuticals (TKMR) that its Phase 1 healthy volunteer clinical trial for TKM-Ebola is on clinical hold until the agency receives additional data related to the mechanism of cytokine release observed at higher doses. Once resolved, the trial may proceed to the ascending dose phase of the study.

The company is conducting the trial to assess the safety, tolerability and pharmacokinetics of TKM-Ebola in healthy adult volunteers without administering any steroid pre-medications.

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