Tekmira Pharmaceuticals TKM-Ebola Clinical Trial Approved
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Tekmira is developing TKM-Ebola, a systemically delivered RNAi therapeutic that utilizes Tekmira's lipid nanoparticle (LNP) delivery technology, for the treatment of Ebola virus infection. There are no approved treatments for Ebola or other hemorrhagic fever viruses. Preclinical studies published in the medical journal The Lancet demonstrated that when small interfering RNA (siRNA) targeting the Ebola virus and delivered by Tekmira's LNP technology were used to treat previously infected non-human primates, the result was 100 percent protection from an otherwise lethal dose of Zaire Ebola virus (Geisbert et al., The Lancet, Vol 375, May 29, 2010).
"We are pleased to have received the FDA's approval of our TKM-Ebola IND. With this approval, we remain on track to achieve another significant milestone for the company by initiating the Phase 1 clinical trial of this product in early 2012," said Dr. Mark J. Murray, Tekmira's President and CEO.
"TKM-Ebola is being developed under a $140 million contract awarded to us by the U.S. Government's Transformational Medical Technologies (TMT) Program. We look forward to continuing this successful collaboration to drive the TKM-Ebola program forward in clinical development," added Dr. Murray.
In addition to the TKM-Ebola product development work sponsored by TMT, this program has supported further development of Tekmira's LNP technology, resulting in a successful 100-fold scale up of the LNP manufacturing process as well as the development of lyophilization (freeze drying) processes while maintaining key LNP product characteristics. These advances will support the late stage clinical development and commercialization of TKM-Ebola and Tekmira's other LNP products.
Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira's LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners.
About the Phase 1 TKM-Ebola Clinical Trial
The Phase 1 TKM-Ebola clinical trial is a placebo-controlled, single-blind, single-ascending dose study with additional multiple-ascending dose cohorts in healthy human volunteers. The objective of the Phase 1 trial is to assess the safety and tolerability of TKM-Ebola and evaluate the pharmacokinetics and systemic exposure following both a single-ascending dose and multiple-ascending doses of TKM-Ebola. TKM-Ebola will be developed under specific FDA regulatory guidelines (called the "Animal Rule"), which are designed to advance therapeutics that cannot meet the requirements for traditional approval because human efficacy studies are not feasible.
