Tekmira's TKM-Ebola Phase I trial placed on clinical hold
The TKM-Ebola Phase I clinical trial is a randomized, single-blind, placebo-controlled study and involves both single ascending and multiple ascending doses of TKM-Ebola. The study is meant to assess the tolerability, safety and pharmacokinetics of administering TKM-Ebola to healthy adult volunteers without any steroid pre-medications.
Tekmira received verbal notice of the hold from the U.S. Food and Drug Administration (FDA).
"We have completed the single ascending dose portion of this study in healthy volunteers without the use of steroid pre-medication," Mark Murray, the president and CEO of Tekmira Pharmaceuticals, said. "The FDA has requested additional data related to the mechanism of cytokine release, observed at higher doses, which we believe is well understood, and a protocol modification designed to ensure the safety of healthy volunteer subjects, before we proceed with the multiple ascending dose portion of our TKM-Ebola Phase I trial."
TKM-Ebola is an anti-Ebola virus RNAi therapeutic that is being developed under a $140 million contract with the DoD's Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office. In March, Tekmira was granted a fast track designation from the FDA for the development of TKM-Ebola.
"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," Murray said.
Tekmira seeks to advance novel RNAi therapeutics and provide its lipid nanoparticle delivery technology to pharmaceutical partners.