# Tekmira

<span style="font-weight: 400;">Around the time of the Ebola outbreak, before the first cases were confirmed/made public, came this announcement:</span>

<span style="font-weight: 400;">VANCOUVER, Jan. 14, 2014 </span>[<span style="font-weight: 400;">GLOBE NEWSWIRE</span>](https://www.globenewswire.com/news-release/2014/01/14/602429/10064229/en/Tekmira-Doses-First-Subject-in-Human-Clinical-Trial-of-TKM-Ebola.html)<span style="font-weight: 400;"> -- *Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced that it* </span>***has dosed**<span style="font-weight: 400;"> the first subject in a Phase I human clinical trial of TKM-Ebola, an anti-Ebola viral therapeutic that is being developed under a </span>**US$140 million contract**<span style="font-weight: 400;"> with the **U.S. Department of Defense**.</span>*

<span style="font-weight: 400;">Nice money if you can get it! Since Anthrax, if your project has got anything to do with the non-existent threat of bioterrorism, then there’s a bottomless pit of public money to support it. </span>

[<span style="font-weight: 400;">Dr. Mark J. Murray, Tekmira's President and CEO:</span>](https://www.globenewswire.com/news-release/2014/01/14/602429/10064229/en/Tekmira-Doses-First-Subject-in-Human-Clinical-Trial-of-TKM-Ebola.html)<span style="font-weight: 400;"> </span>*<span style="font-weight: 400;">Building upon our </span>****compelling preclinical results****<span style="font-weight: 400;">, the Phase I data generated will guide our determination of the appropriate dose of this drug for the potential use as a medical countermeasure against this lethal hemorrhagic fever virus. We remain on track to have data from this trial available in the second half of this year.</span>*

<span style="font-weight: 400;">Four things: </span>

1. <span style="font-weight: 400;">The trial was [conducted in](https://www.wsj.com/articles/researchers-put-brakes-on-study-of-tekmira-ebola-drug-in-west-africa-1434732833) Sierra Leone   
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2. <span style="font-weight: 400;">The compelling </span>*<span style="font-weight: 400;">preclinical </span>*<span style="font-weight: 400;">results claimed 100% efficacy in non-human primates - using the Zaire version of Ebola known as Kikwit-95 to infect macaques.  
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3. <span style="font-weight: 400;">The data never did become available. Including details of how the trial subjects were tested or *tolerability* (adverse effects).  
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4. <span style="font-weight: 400;">Tekmira experienced a [huge stockmarket surge](https://www.businessinsider.com.au/tekmira-shares-rally-again-august-11-2014-8) due to the drug x DoD deal.</span>

<span style="font-weight: 400;">Following the outbreak 2014, Tekmira tweaked their RNAi drug to target the Guinea version of Ebola, but the trial was unceremoniously halted due to a lack of efficacy.</span>

[<span style="font-weight: 400;">Peter Horby, </span>**Oxford**<span style="font-weight: 400;">, study head (June 2015):</span>](https://www.wsj.com/articles/researchers-put-brakes-on-study-of-tekmira-ebola-drug-in-west-africa-1434732833) *It is a great tribute to the team in Sierra Leone that the trial has been run so efficiently and that we now have substantial experience on the use of TKM-Ebola-Guinea in patients with Ebola. While the trial has reached a statistical endpoint, final conclusions on the efficacy and tolerability of the drug must await full analysis of the data*.

So what does *statistical endpoint* mean exactly? Hope you don't mean the subjects met a statistical endpoint ...

*<span style="font-weight: 400;">The drug has not demonstrated an overall therapeutic benefit. But we need time to look at all the data to interpret that in the context of the patient mix and other variables</span>*<span style="font-weight: 400;">. </span>*<span style="font-weight: 400;">Final conclusions on efficacy and **tolerability** must await full analysis.</span>*

<span style="font-weight: 400;">That analysis is still *must awaiting* publication.  
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[<span style="font-weight: 400;">Then there’s this:</span>](https://www.proactiveinvestors.com.au/companies/news/115413/tekmira-pharmaceuticals-gives-up-research-on-ebola-treatment-to-focus-on-hepatitis-b-115413.html) *<span style="font-weight: 400;">Tekmira’s TKM-Ebola </span>*<span style="font-weight: 400;">(subsequent)</span>*<span style="font-weight: 400;"> trials in Guinea started .. with financial and **other support** from British NGO Wellcome Trust.</span>*

<span style="font-weight: 400;">Hmm. So we’ve got Andersen, Garry, Holmes, Rambaut, Oxford (Horby - head of the RECOVERY trial coordinated by Farrar that killed-off Hydroxy by </span>[<span style="font-weight: 400;">overdosing the trial patients</span>](https://www.nejm.org/doi/full/10.1056/NEJMc2035374)<span style="font-weight: 400;">), Springer </span>*<span style="font-weight: 400;">Nature (</span>*[*<span style="font-weight: 400;">Stefan Von Holtzbrinck</span>*](https://www.irishtimes.com/opinion/empire-of-publishing-built-on-barbarism-1.164668)<span style="font-weight: 400;"> - his father was publisher for the Nazis), and Wellcome Trust (Farrar).</span>

<span style="font-weight: 400;">All thereabouts in the Ebola 14 outbreak. If the plot gets any thicker we could stand a spoon up in it. </span>

<span style="font-weight: 400;">Finally, in 2015, the Tekmira/Wellcome/US Dept Defense drug trial was cancelled when it came to a *statistical endpoint*. Had a great ride on the stockmarket before that though if you were a shrewd investor. Tekmira dropped all interest in researching Ebola from 2015 on.</span>

<span style="font-weight: 400;">You could call this a strange set of coincidences, but </span>[Dr. Cyril Broderick](http://thepatrioticvanguard.com/ebola-horror-story)**,** Liberian scientist didn't:

*<span style="font-weight: 400;">DoD gave a contract worth $140 million dollars to Tekmira .. to conduct Ebola research. This research work involved injecting and infusing healthy humans with the deadly Ebola virus. The DoD is listed as a collaborator in a ‘First in Human Ebola clinical trial’ (NCT02041715), which started in January 2014 shortly before an Ebola epidemic was declared in West Africa in March.</span>*<span style="font-weight: 400;"> </span>

<span style="font-weight: 400;">I'm not sure that's true. I know it was a rumour going around. The Jan 2014 event was a Phase 1 trial. It had already been [pre-clinically trialed](https://www.thelancet.com/article/S0140-6736(10)60357-1/fulltext) on macaques in a biosafety-level-4 biocontainment at the US Army Medical Research Institute of Infectious Disease. Lancet published a paper on it: </span>

[<span style="font-weight: 400;">Lancet/Tekmira,</span>](https://www.thelancet.com/article/S0140-6736(10)60357-1/fulltext)*<span style="font-weight: 400;"> Post exposure protection of nonhuman primates against a lethal Ebola virus challenge with RNA interference: </span>*

*<span style="font-weight: 400;">The monkeys were then placed in primate jackets, returned to their cages, and tethered. After 7 days, the animals were inoculated intramuscularly with a target dose .. of ZEBOV (Kikwit strain)</span>*

<span style="font-weight: 400;">I wonder if people haven't got this trial confused with what happened in Sierra Leone.</span>

<span style="font-weight: 400;">I'm not easily shocked but i would be if they were injecting and infusing healthy humans with the deadly Ebola virus. Surely Tekmira was only testing tolerability. Details of the trial *are* scant though. </span>

<span style="font-weight: 400;">It is also odd why Tekmira would go to Sierra Leone to test an Ebola drug - if it's only about tolerability. Remembering the first trial was at least a month before the outbreak was known, and Sierra Leone had never had an Ebola outbreak. </span>