Skip to main content
Premium Trial:

Request an Annual Quote

Tekmira Gets FDA OK for Ebola Drug Use in Infected Individuals


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."

The Scan

Cancer Survival Linked to Mutational Burden in Pan-Cancer Analysis

A pan-cancer paper appearing in JCO Precision Oncology suggests tumor mutation patterns provide clues for predicting cancer survival that are independent of other prognostic factors.

Australian Survey Points to Public Support for Genetic Risk Disclosure in Relatives of At-Risk Individuals

A survey in the European Journal of Human Genetics suggests most adult Australians are in favor of finding out if a relative tests positive for a medically actionable genetic variant.

Study Links Evolution of Stony Coral Skeleton to Bicarbonate Transporter Gene

A PNAS paper focuses on a skeleton-related bicarbonate transporter gene introduced to stony coral ancestors by tandem duplication.

Hormone-Based Gene Therapy to Sterilize Domestic Cat

A new paper in Nature Communication suggests that gene therapy could be a safer alternative to spaying domestic cats.