April 10, 2015 / 1:20 PM / 4 years ago

FDA modifies partial clinical hold on Tekmira Ebola study

(Reuters) - Tekmira Pharmaceuticals Corp said the U.S. Food and Drug Administration would allow the company to continue testing its experimental Ebola treatment at a lower dose, altering the terms of a partial clinical hold on the study.

The company’s application to study the treatment, TKM-Ebola, remains on partial clinical hold for doses above 0.24 mg/kg per day, Tekmira said on Friday.

The FDA placed Tekmira’s early-stage study on a clinical hold in July, asking the company for data on how the therapy works and requesting a change to design of the study related to multiple dosing.

The clinical hold was modified in August into a partial hold asking only for a change in the study design.

Tekmira had reported interim results in May showing that a higher dose of 0.30 mg/kg per day was well-tolerated.

Tekmira said it plans to resume the early study in the coming weeks, and expects results from the study in the second half of 2015.

Tekmira shares rose about 2 percent to $17.95 following the lifting of a trading halt imposed at 8.30 a.m. ET.

Reporting by Vidya L Nathan in Bengaluru; Editing by Ted Kerr

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