Tekmira presents Phase I results of Ebola vaccine trial
Tekmira is developing TKM-Ebola, an anti-Ebola virus RNAi therapeutic, as part of a $140 million contract with the Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office. After completing the single ascending dose portion of the trial, TKM-Ebola was well tolerated at a dose level of 0.3 milligrams per kilogram.
Tekmira said the TKM-Ebola drug exposure levels achieved in the trial's subjects demonstrate that the multiple ascending dose portion of the trial will achieve drug exposure levels previously shown to confer complete protection against lethal Ebola virus inoculum in non-human primates.
The results of the trial were presented on Wednesday at the 17th Annual Meeting of the American Society of Gene and Cell Therapy in Washington.
"(Wednesday), Dr. Ian MacLachlan presented positive clinical data which further validates our (stable nucleic acid-lipid particles (LNP)) technology and demonstrates progress within both our anti-viral and oncology programs," Mark Murray, the president and CEO of Tekmira, said. "The TKM-Ebola Phase I trial results are significant as they establish the safety of 'third generation' LNP formulations and confirm that dosing at efficacious levels may be accomplished without the need for pre-medication. We are encouraged by these technology advances and they will support the development of Tekmira's other anti-viral therapeutics."
Tekmira said the safety profile and pharmacokinetics observed in the single dose portion of the study support initiation of the multiple ascending dose portion of the trial. The company anticipates the study will be completed in the second half of 2014.