Chimerix, an anti viral which if approved could be used for CFS, is in publicity storm

[Fuschia]

http://edition.cnn.com/2014/03/11/health/josh-hardy-drug-study/

A kid with a suppressed immune system and a life threatening adenovirus has been granted a compassionate use treatment with chimerix. The company that makes the drug was initially arguing that granting it could slow its FDA approval process, anyone know how true this is? Also, any implications for Rituximab, or is it only in cases where the disease is life threatening?

 

[Daffodil]

do you mean the drug cmx001?

 

[Valentijn]

http://edition.cnn.com/2014/03/11/health/josh-hardy-drug-study/

A kid with a suppressed immune system and a life threatening adenovirus has been granted a compassionate use treatment with chimerix. The company that makes the drug was initially arguing that granting it could slow its FDA approval process, anyone know how true this is? Also, any implications for Rituximab, or is it only in cases where the disease is life threatening?

It's not just life threatening ... it's when the person IS going to die.

The problem is that while the drug might save the patient, odds are still very much that they'll die. And the drug developer has to report that when seeking approval, which can result in a delay or refusal of approval. Basically the FDA allows the drug to be used in circumstances like these, but then punishes the drug company for agreeing to let the patient use the drug.

 

[Fuschia]

The kid had cancer of the kidneys apparently. One of the biggest things they were worried about with CMX 001 was the potential for kidney damage, I can see why the company were leery about having him in their trial. Absolutely, within reason, the FDA should allow compassionate use treatment without requiring the patient to be part of a trial. If someone is willing to take that chance, and there's almost a certainty of death otherwise, what is there to lose?

 

[Valentijn]

Fortunately the latest news is that the kid is beating the viral infection which was killing him and it should be entirely gone soon. It sounds like the unapproved drug used isn't one known to cause kidney damage, but the less effective drug which they were using previously does cause kidney damage. Currently he's on dialysis 3 times per week, and they don't know if that will be permanent.

 

[Sushi]

http://edition.cnn.com/2014/03/11/health/josh-hardy-drug-study/

A kid with a suppressed immune system and a life threatening adenovirus has been granted a compassionate use treatment with chimerix. The company that makes the drug was initially arguing that granting it could slow its FDA approval process, anyone know how true this is? Also, any implications for Rituximab, or is it only in cases where the disease is life threatening?

This is the drug that some of us have been waiting for--a new oral and much safer version of Vistide or Cidofovir.

Sushi

 

[SOC]

This is the drug that some of us have been waiting for--a new oral and much safer version of Vistide or Cidofovir.

Sushi

I wonder why they couldn't give the kid Vistide or Cidovir then, and skip all the controversy? A safety issue, maybe?

 

[Tristen]

I wonder why they couldn't give the kid Vistide or Cidovir then, and skip all the controversy? A safety issue, maybe?

Kidney damage is the main concern with Vistide. While on it myself, I had to do labs 3 times a week to monitor mostly the kidneys. Makes since that cmx001 would be safer, but I don't know that it's necessarily more effective because the last I heard that was just an expectation requiring completion of clinical trials for the determination. My year on vistide showed it to be very effective. If cmx001 is more effective than that, we have a really wonderful drug in pipeline.

 

[Cheesus]

Fortunately the latest news is that the kid is beating the viral infection which was killing him and it should be entirely gone soon. It sounds like the unapproved drug used isn't one known to cause kidney damage, but the less effective drug which they were using previously does cause kidney damage. Currently he's on dialysis 3 times per week, and they don't know if that will be permanent.

What fantastic news! Primarily for the kid and his family, but then also great news for us and all others who could benefit from this drug

 

[Sushi]

I wonder why they couldn't give the kid Vistide or Cidovir then, and skip all the controversy? A safety issue, maybe?

Yes, as Tristen said, cidofovir has safety issues. It is a drug that many doctors won't risk giving.

Sushi

 

[Hip]

Apparently the CMX001 drug, also known as brincidofovir, is "one the ten hot topics in antiviral research."

Some info:

CMX001 – The Future Vistide?

Dr. Peterson didn’t report on CMX001 in Paris, but sitting in the background of all this is a analogue of Vistide called CMX001 which appears to be a safer and more effective, if not yet available, version of it. A 2012 review named CMX001 as one the ‘ten hot topics’ in antiviral research.

Chimerix Pharmaceuticals modified Vistide so that it can easily be taken up into the tissues. That means no need for infusions, no worries about kidney problem and according to Chimerix, dramatically increased effectiveness.

CMX001 has been in development for some time but just this March the FDA awarded the drug ‘fast track’ status for the prevention of cytomegalovirus infection. Phase II trials are finished and Phase III trials will get underway this year.

Given Dr. Peterson’s success with Vistide, FDA approval of CMX001 could be very good news for ME/CFS patients with HHV6, HCMV and/or possibly EBV infections.

Source: here.

Increased Safety

Chimerix has modified Vistide so that its more easily taken up into the tissue – thereby eliminating the need for infusions and the possibility of kidney damage. Chimerix’s new ‘packaging’ process is innovative enough for CMX001 to be considered a ‘new chemical entity’ and be protected by patent laws CMX001’s only toxicity worries appear to involve the gastrointestinal system which Chimerix reports are ‘easily monitored and rapidly reversible’.

Increased Effectiveness

Chimerix states CMX001 is not just a little bit more, or even moderately more, but ‘much more potent’ than the original drug (Vistide) in in vitro studies against a wide variety of viruses. A 2012 review named CMX001 as one the ‘ten hot topics’ in antiviral research.

Source: here.

 

[Tristen]

This is going to be great stuff for a good percentage of us. I'm wondering if maintenance usage is going to be possible....oh well, may not be necessary. My year on Vistide did put the CMV completely down, and it remains undetectable after 4 years. Also at that time, the EBV went back into remission, but it's not definite the drug did that. It could have been my improved immune function. I also believe (along with my doc) there's a good possibility the drug was hitting another undiagnosed virus.

 

[Ema]

I don't want to wait another two years for this drug. I'm ready now!

 

[SOC]

I don't want to wait another two years for this drug. I'm ready now!

I was ready 5 years ago.