NEW YORK (GenomeWeb) – Tekmira Pharmaceuticals announced last week that the US Food and Drug Administration has modified the hold it placed on the use of the company's investigational Ebola drug TKM-Ebola and will permit its use in infected individuals.
In late July, Tekmira announced that the agency had halted the multiple ascending dose portion of a Phase I study of TKM-Ebola in healthy volunteers until the company provided additional information about cytokine induction observed in those who had received the highest dose of the drug in the trial's single-dose arm.
Notably, none of the trial participants are receiving pre-medication to address siRNA-related immune responses — something that Tekmira had included in previous clinical studies of other drugs but does not intend to do with TKM-Ebola.
Tekmira said that the FDA is also asking that the Phase I trial's protocols be amended "ensure the safety of healthy volunteers" in the multiple ascending dose portion of the trial.
While the company does so, it has now been cleared to provide TKM-Ebola to treat infected individuals in light of the Ebola outbreak in Western Africa. The hold remains on the clinical trial.
"We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients," Tekmira President and CEO Mark Murray said in a statement.
"We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola," he added. "We recognize the heightened urgency of this situation and are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols."