Brincidofovir fails Phase III CMV trial.

Who Me?

Well-Known Member
Brincidofovir fails Phase III CMV trial


Brincidofovir fails Phase III CMV trial. Did physicians mistake diarrhea for GVHD?
Chimerix announced that the Phase III trial of brincidofovir has failed to meet its primary endpoint of suppressing CMV infection through week 24 after hematopoietic cell transplant (HCT) patients. Although the drug showed impressive suppression of CMV infections during the 14 week trial, infections soared during the 10-week observation period that followed. One theory presented by the company’s CEO is that physicians may have mistaken drug related diarrhea for GHVD and administered unnecessary steroids.
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Cort

Founder of Health Rising and Phoenix Rising
Staff member
Brincidofovir fails Phase III CMV trial


Brincidofovir fails Phase III CMV trial. Did physicians mistake diarrhea for GVHD?
Chimerix announced that the Phase III trial of brincidofovir has failed to meet its primary endpoint of suppressing CMV infection through week 24 after hematopoietic cell transplant (HCT) patients. Although the drug showed impressive suppression of CMV infections during the 14 week trial, infections soared during the 10-week observation period that followed. One theory presented by the company’s CEO is that physicians may have mistaken drug related diarrhea for GHVD and administered unnecessary steroids.
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http://hhv6foundation.wpengine.com
Bummer! This (CMX001) looks like a great drug.......I asked Kristin about this - she said the government will not allow this drug to fail and we will hear more from it in the future.
 

Strike me lucky

Well-Known Member
Sounds like it works while on the drug but when stopped viruses reactivate. No different to any avs in cfs really.

Maybe another trial while trying to reduce steroids being used. Or another trial for a different virus to get it approved such as hhv1 or 2 and shingles. Then it could be used off label much like other avs now.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
This is terrible news.
I'm not sure how I feel about the government not allowing this drug to fail either...I mean, if it doesn't work, shouldn't we want it to fail?
I actually haven't read the article (lol) but my sense is that Kristin feels it really is a very valuable and needed drug and that they screwed up in how they did the trial and when they do the trial correctly it will do good. This drug was so promising - it seemed to have everything going for it. Hopefully they just did the wrong trial.
 

Strike me lucky

Well-Known Member
I actually haven't read the article (lol) but my sense is that Kristin feels it really is a very valuable and needed drug and that they screwed up in how they did the trial and when they do the trial correctly it will do good. This drug was so promising - it seemed to have everything going for it. Hopefully they just did the wrong trial.

If it gets approved for something else we could then use it off label anyway, i hope. The study sounded like it worked well while on the drug but coming off is an issue for ones immune system to take over??
 

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