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Berlin Cures Phase II trial

Belbyr

Belbyr

Senior Member
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602
Location
Memphis
https://berlincures.de/pipeline/

https://berlincures.de/news-berlin-...nd-implementation-of-phase-2-study-of-bc-007/

4pDScEx.jpg


Looks like the drug is safe after phase I. I'm anxiously awaiting to see how this drug does for the POTS and a portion of the CFS community.
 
alex3619

alex3619

Senior Member
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13,810
Location
Logan, Queensland, Australia
Belbyr said:
I'm not aware such a type of drug has been tried before?
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Most phase 3 trials fail, and a great many phase 2. It was a comment about the likelihood of success. However, eventually, one such trial will succeed. More will follow. Treatments will enter the market. We just don't know if its this trial, you can never tell before the results are in. You can hope, but never be certain.
 
Belbyr

Belbyr

Senior Member
Messages
602
Location
Memphis
Not disagreeing with you. Many phase 3's do, but as time goes on... phase 3 trials are getting better and success rates are increasing compared to the 90's. I also read that if there is a specific biomarker that can be tracked, that alone increases the chances of success by 50% alone. I think this one has a biomarker that is being measured. Apparently they were able to see these markers go down in the phase I trial of healthy people that had a small amount of these antibodies with no side effects. Though I could be wrong.
 
alex3619

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
The problem with them tracking a biomarker is we still do not know if the biomarker is important. This trial will help determine that. So it does not matter if its going down or not, unless its important. The science is not there yet.

Treating autoantibodies was also what the Rituximab trial was about, and its still not determined that Rituximab is a good general therapy. We are also still not sure of subgroups. Science takes time, and sometimes a great many studies by a great many research groups.
 
SWAlexander

SWAlexander

Senior Member
Messages
1,944
alex3619 said:
Most such trials fail. They keep failing till one succeeds. Is this the one? From what I read just now it looks like a good candidate.
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Medically Unexplained Symptoms are Psychosomatic? Psychosomatic illnesses are medically unexplained.
I agree 1000%.
No psychosomatic drug has ever "cured" the underlining cause.
However, a Netflix original series “Human: The World Within – part 3 Defend” showed (40 minutes in) how a trail doctor successful removed antibodies and used a young man`s own T-cells to cure leukemia.
Besides, reading many scientific papers, this Netflix original series Human: The World Within explains many still open question regarding our Immune system. Worth watching.
 
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