8/7/2014 3:22:19 PM
Tekmira Pharmaceuticals Ebola Drug May Be Used On Infected Patients: FDA
August 8, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration announced on Aug. 7 that it had modified its clinical hold status on Tekmira Pharmaceuticals' (TKMR) experimental Ebola treatment. As a result, its treatment may start to be used in patients with the potentially fatal disease.
Following the news, shares of Tekmira quickly rose 18 percent in New York, marking the biggest increase it has seen since March.
The FDA previously put the drug, which is named TKM-Ebola, on hold for approval. Ebola has killed more than 900 people in West Africa since March, which plays a role in the FDA’s choice to reconsider TKM-Ebola.
“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,” Tekmira’s Chief Executive Officer Mark Murray told Bloomberg. “The foresight shown by the FDA removes one potential roadblock to doing so.”
Stephanie Yao, a spokesperson for the FDA, was relatively mum when asked about the situation. She would not comment on whether the administration is beginning testing, only specifying that it’s considering doing so. Yao would also not say how much of the drug is available for the purpose of being used in the fight against Ebola.
Next week, the World Health Organization is expected to hold a meeting with experts in health ethics to determine if experimental Ebola drugs have a place in the war against the disease.
Kent Brantly and Nancy Writebol, two Ebola aids who became infected while treating patients, were recently administered Mapp Biopharmaceutical Inc.’s experimental therapy called ZMapp in Liberia before flying back to the U.S. Since arriving in the U.S., the two have shown signs of improvement at Emory University Hospital in Georgia. This instance may encourage health ethics experts to lean toward promoting experimental Ebola treatments.
Tekmira initially stopped testing its drug, TKM-Ebola, after healthy volunteers who were receiving it began to show flu-like symptoms. Initially, the company said it was looking to resolve this issue by the end of the year. However, it seems like it has a realistic potential to go into use sooner than this time frame.
Yao could not comment on the development of TKM-Ebola on the behalf of the FDA. She only specified that the administration analyzes each drug’s human studies based on both the risks and benefits involved.
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