Shares of Tekmira Pharmaceuticals are up by around 16% in premarket trading.
“[T]he U.S. Food & Drug Administration (FDA) has verbally confirmed they have modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application (IND) to a partial clinical hold,” they said. “This action enables the potential use of TKM-Ebola in individuals infected with Ebola virus.”[eap_ad_2]
“Earlier this month, the agency put a hold on a Tekmira Pharmaceuticals Corp clinical trial of TKM-Ebola, one of the few Ebola treatments advanced enough to be tested in people,” reported Reuters’ Julie Steenhuysen. This had enraged the the families of those infected by the deadly virus, which has been killing people across Western Africa.
“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,” said Tekmira CEO Mark Murray on Thursday. “The foresight shown by the FDA removes one potential roadblock to doing so. This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus. 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.”[eap_ad_3]