By RTT News,
July 03, 2014, 03:24:00 AM EDT
(RTTNews.com) - Tekmira Pharmaceuticals Corp. (TKMR, TKM.TO) announced that it has received verbal notice from the U. S. Food and Drug Administration or FDA that the TKM-Ebola Phase I healthy volunteer clinical study has been placed on clinical hold. This notice applies only to this study.
The company stated that it has completed the single ascending dose portion of this study in healthy volunteers without the use of steroid pre-medication. The FDA has requested additional data related to the mechanism of cytokine release, observed at higher doses, which the company believes is well understood, and a protocol modification designed to ensure the safety of healthy volunteer subjects, before the company proceeds with the multiple ascending dose portion of its TKM-Ebola Phase I trial.
"We will continue our dialogue with the FDA, provided for under our Fast Track status, in order to advance the development of this important therapeutic agent," said Dr. Mark Murray, President and CEO of Tekmira Pharmaceuticals.
The TKM-Ebola Phase I clinical trial is a randomized, single-blind, placebo-controlled study and involves single ascending doses and multiple ascending doses of TKM-Ebola. The study is assessing the safety, tolerability and pharmacokinetics of administering TKM-Ebola to healthy adult volunteers without administering any steroid pre-medications.
TKM-Ebola, an anti-Ebola virus RNAi therapeutic, is being developed under a $140 million contract with the U.S. Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office.
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