In January 2014, Tekmira started a Phase I clinical trial of TKM-Ebola to assess its safety in healthy people with a dose of 0.24 mg/kg/day for seven day treatment. The FDA put the trial on clinical hold in July 2014 to assess results, after some subjects had flu-like responses.<ref>Cynthia Koons, Caroline Chen and Robert Langreth for Bloomberg News. Aug 8, 2014 [http://www.bloomberg.com/news/2014-08-07/ebola-drug-by-tekmira-may-be-used-on-infected-patients-fda-says.html Ebola Drug by Tekmira May Be Used on Infected Patients]</ref> In August, the FDA changed the status to "partial hold", allowing the drug to be used under [[Expanded access]] in people infected with Ebola but with the Phase I trial still suspended.<ref name="Kroll" /> In April 2015 the FDA allowed the study to resume at a lower dose.<ref>{{cite web|title=FDA modifies partial clinical hold on Tekmira Ebola study|url=http://www.reuters.com/article/2015/04/10/us-health-ebola-tekmira-idUSKBN0N11AF20150410|publisher=Reuters|accessdate=1 August 2015}}</ref>
In January 2014, Tekmira started a Phase I clinical trial of TKM-Ebola to assess its safety in healthy people with a dose of 0.24 mg/kg/day for seven day treatment. The FDA put the trial on clinical hold in July 2014 to assess results, after some subjects had flu-like responses.<ref>Cynthia Koons, Caroline Chen and Robert Langreth for Bloomberg News. Aug 8, 2014 [http://www.bloomberg.com/news/2014-08-07/ebola-drug-by-tekmira-may-be-used-on-infected-patients-fda-says.html Ebola Drug by Tekmira May Be Used on Infected Patients]</ref> In August, the FDA changed the status to "partial hold", allowing the drug to be used under [[Expanded access]] in people infected with Ebola but with the Phase I trial still suspended.<ref name="Kroll" /> In April 2015 the FDA allowed the study to resume at a lower dose.<ref>{{cite web|title=FDA modifies partial clinical hold on Tekmira Ebola study|url=http://www.reuters.com/article/2015/04/10/us-health-ebola-tekmira-idUSKBN0N11AF20150410|publisher=Reuters|accessdate=1 August 2015}}</ref>
A Phase II trial started on 11 March 2015 in Sierra Leone, West Africa and stopped enrolling new subjects on 19 June 2015 after it appeared not to work.<ref>{{cite news|last1=Kupferschmidt|first1=Kai|title=New Ebola drug trial starts in Sierra Leone|url=http://news.sciencemag.org/africa/2015/03/new-ebola-drug-trial-starts-sierra-leone|accessdate=1 August 2015|work=Science Magazine|publisher=AAAS|date=11 March 2015}}</ref><ref>{{Cite web | last1 = Vogel | first1 = Gretchen | last2 = Kupferschmidt | first2 = Kai | date = 19 June 2015 | title = In setback for potential Ebola drug, company halts trial | url = http://news.sciencemag.org/africa/2015/06/setback-potential-ebola-drug-company-halts-trial | website = news.sciencemag.org | accessdate = 24 June 2015 }}</ref> In July 2015 the company announced it was suspending development on the drug, changing its name, and changing its focus to [[HBV]].<ref>Lisa Schnirring for CIDRAP News. Jul 20, 2015 [http://www.cidrap.umn.edu/news-perspective/2015/07/experimental-ebola-drug-shelved-study-explores-virus-clearance Experimental Ebola drug shelved; study explores virus clearance]</ref>
A Phase II trial started on 11 March 2015 in Sierra Leone, West Africa and stopped enrolling new subjects on 19 June 2015 after it appeared not to work.<ref>{{cite news|last1=Kupferschmidt|first1=Kai|title=New Ebola drug trial starts in Sierra Leone|url=http://news.sciencemag.org/africa/2015/03/new-ebola-drug-trial-starts-sierra-leone|accessdate=1 August 2015|work=Science Magazine|publisher=AAAS|date=11 March 2015}}</ref><ref>{{Cite web | last1 = Vogel | first1 = Gretchen | last2 = Kupferschmidt | first2 = Kai | date = 19 June 2015 | title = In setback for potential Ebola drug, company halts trial | url = http://news.sciencemag.org/africa/2015/06/setback-potential-ebola-drug-company-halts-trial | website = news.sciencemag.org | accessdate = 24 June 2015 }}</ref> In July 2015 the company announced it was suspending development on the drug, changing its name, and changing its focus to developing treatments for [[Hepatitis B virus]].<ref>Lisa Schnirring for CIDRAP News. Jul 20, 2015 [http://www.cidrap.umn.edu/news-perspective/2015/07/experimental-ebola-drug-shelved-study-explores-virus-clearance Experimental Ebola drug shelved; study explores virus clearance]</ref>
==See also==
==See also==
Revision as of 05:45, 17 May 2016
Ebola virus
TKM-Ebola is an experimental antiviral drug for Ebola disease being developed by Arbutus Biopharma (formerly Tekmira Pharmaceuticals Corp.)[1] in Vancouver, Canada.[2] The drug candidate was formerly known as Ebola-SNALP.[3]
Ebola Pathenogensis path
TKM-Ebola is a combination of small interfering RNAs targeting three of the seven proteins in Ebola virus: Zaire Ebola L polymerase, Zaire Ebola membrane-associated protein (VP24), and Zaire Ebola polymerase complex protein (VP35).[2][3] By down-regulating these three protein, TKM-Ebola inhibit virus replication that eliminate the infection. The drug was effective in rhesus monkeys infected with Ebola.[4] After the Ebola outbreak in West Africa in 2014, the new variant responsible for was isolated from several Ebola virus family and the specific genomic sequence was determined. The company re-designed TKM-Ebola and termed as "TKM-Ebola-Guinea".[5]
In January 2014, Tekmira started a Phase I clinical trial of TKM-Ebola to assess its safety in healthy people with a dose of 0.24 mg/kg/day for seven day treatment. The FDA put the trial on clinical hold in July 2014 to assess results, after some subjects had flu-like responses.[6] In August, the FDA changed the status to "partial hold", allowing the drug to be used under Expanded access in people infected with Ebola but with the Phase I trial still suspended.[2] In April 2015 the FDA allowed the study to resume at a lower dose.[7]
A Phase II trial started on 11 March 2015 in Sierra Leone, West Africa and stopped enrolling new subjects on 19 June 2015 after it appeared not to work.[8][9] In July 2015 the company announced it was suspending development on the drug, changing its name, and changing its focus to developing treatments for Hepatitis B virus.[10]
^ ab"TKM-Ebola". BioCentury. BioCentury Publications Inc. Retrieved 1 August 2015.
^Thi, Emily P.; Mire, Chad E.; Lee, Amy C. H.; Geisbert, Joan B.; Zhou, Joy Z.; Agans, Krystle N.; Snead, Nicholas M.; Deer, Daniel J.; Barnard, Trisha R.; Fenton, Karla A.; MacLachlan, Ian; Geisbert, Thomas W. (22 April 2015). "Lipid nanoparticle siRNA treatment of Ebola-virus-Makona-infected nonhuman primates". Nature. 521 (7552): 362–365. doi:10.1038/nature14442.
