Following an outcry from disease expert Jeremy Farrar to provide experimental Ebola drugs and vaccines to those suffering in West Africa, the US Food and Drug Administration has placed Tekmira Pharmaceuticals Corp.'s Ebola drug trial on hold.
Due to safety concerns, the FDA is delaying human trials of the drug and requesting more information from Tekmira. It's currently in the first of three stages of clinical trials that are conducted prior to approval by an FDA panel. The randomized, single-blind, placebo-controlled study was assessing the safety, tolerability, and pharmacokinetics of the drug prior to it being put on hold.
Such timing is poor because the roaring Ebola virus outbreak in West Africa - particularly concentrated in Guinea, Liberia, and Sierra Leone - needs drastic and immediate support from international officials. The World Health Organization (WHO) announced a two-day Ebola virus conference for July 2-3 with a number of knowledgeable people in order to mitigate the magnitude of the outbreak. The WHO will hold a press conference on Thursday from 5:30 p.m. to 6:30 p.m.
TKM-Ebola, Tekmira's drug, is being developed under a $140 million contract with the US Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office. The hold on the study comes after the FDA granted Tekmira a Fast Track designation for the Ebola drug in March.
"We have completed the single ascending dose portion of this study in healthy volunteers without the use of steroid pre-medication. The FDA has requested additional data related to the mechanism of cytokine release, observed at higher doses, which we believe is well understood, and a protocol modification designed to ensure the safety of healthy volunteer subjects, before we proceed with the multiple ascending dose portion of our TKM-Ebola Phase I trial," said Dr. Mark Murray, President and CEO of Tekmira Pharmaceuticals, in this Wall Street Journal article.
As a world leader in pharmaceuticals (an industry worth of about $300 billion per year), it's likely the United States is at the forefront of developing experimental Ebola drugs. Although such information is not clear (even though Farrar says it's 'ridiculous' that none have been approved for human testing), West Africa is in dire need of a solution after Ebola cases and deaths have witnessed a resurgence in the past week.
For now, the TKM-Ebola drug trial will be put on hold, but we will find out more regarding the Ebola virus issue when the WHO holds their press conference later today.
You can read more about TKM-Ebola in this Bloomberg Businessweek article.
