Tekmira anticipates resolution of TKM-Ebola Phase I clinical hold
The U.S. Food and Drug Administration previously placed the Phase I trial of TKM-Ebola on clinical hold. Tekmira received the clinical hold letter from the FDA, which confirms the agency is seeking data to clarify the mechanism of potential cytokine release and a modification to the protocol for the multiple ascending dose portion of the trial, according to a Tekmira press release.
"It is important to highlight that the study protocol for the TKM-Ebola Phase I trial called for an interim review of the data from the single ascending dose portion of the trial before proceeding to the multiple ascending dose portion of the study," Mark Murray, the president and CEO of Tekmira, said. "I wish to emphasize this trial is unique. It represents the first RNAi study involving the daily treatment of healthy volunteers, without steroid pre-medication or any other type of pre-medication, and with multiple ascending doses. Furthermore, the multiple ascending dose portion of the study, as originally proposed, reflects the intense dosing regimen that would be used in patients lethally infected with Ebola virus."
On May 21, Tekmira disclosed the results of the single ascending dose portion of the study, which showed the administration of TKM-Ebola was well-tolerated at a dose level of 0.3 milligrams per kilogram. Murray said the results were significant as they established the safety of TKM-Ebola without the need for pre-medication.
"The mechanism for cytokine release is understood and we will be modifying our study protocol to further ensure subject safety," Murray said. "Our team is working expediently to respond to the FDA. We are mindful of the need for this important therapeutic in situations such as the ongoing Ebola outbreak in West Africa. However, TKM-Ebola is currently an unapproved agent and the regulatory framework to support its use in Africa has not been established at this time."
Tekmira said its other clinical development programs were unaffected by the TKM-Ebola clinical hold and all of them remain on track.
TKM-Ebola is an anti-Ebola RNAi therapeutic being developed under a $140 million contract with the DoD's Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office.