E Tekmira Gets The Go-Ahead From The FDA To Continue Its Ebola Drug Study

The FDA has announced today that Tekmira Pharmaceuticals (TKMR) may continue to dose healthy patients in its phase I study with TKM-Ebola drug as long as the company does so with lower doses. The highest dose that can be given to these patients is 0.24 mg/kg per day. Patients will either be given TKM-Ebola 0.24 mg/kg or a placebo compound over a 7 day period as part of a safety study. The company now states that it expect to initiate its phase 1 study in a few weeks and then will possibly have safety data results by the 2nd half of 2015. 

This comes as a huge relief to Tekmira because now it can resume testing in healthy volunteers for its phase 1 program. Back in of 2014 the company announced that the FDA had placed their phase 1 ebola trial on a partial clinical hold because of possible safety issues with doses. No bad side effects had been noted, but the FDA wanted to be cautious using this experimental drug in healthy volunteers. One month after the partial clinical hold the FDA allowed for dosing of TKM-Ebola only in patients suspected of having contracted ebola, or who actually had ebola. Now Tekmira can begin dosing in healthy volunteers for its phase I clinical trial. 

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