Trial Report Plasma cell targeting with the anti-CD38 antibody daratumumab in ME/CFS -a clinical pilot study, 2025, Fluge et al

[Utsikt]

F/M declare at the end of the paper their conflict of interest based on their involvement in a patent owned by Haukeland University Hospital, with F/M listed as inventors (we just don’t know in which jurisdictions the patent is valid).

I think it’s this one:

WO2021038097A1 - Method for the treatment of chronic fatigue syndrome using an inhibitory or cytotoxic agent against plasma cells - Google Patents

The present invention relates in a first aspect to a method for the treatment of chronic fatigue syndrome (CFS) comprising administering to a patient in need thereof a therapeutically effective amount of inhibitory or cytotoxic agent against plasma cells. In a further aspect, the present...

patents.google.com

 

[DiBelloBr]

I don't see patents as being a significant incentive for Fluge and Mella. They have a personal commitment to try to solve a biomedical problem that at least for one of them is very close to home. They don't cut corners. They actually want to get a useful answer. They will have good salaries and live in a nice place.

The chances of Haukeland getting much out of a discovery are probably quite small. I am personally familiar with this situation and pharma lawyers are way ahead of university lawyers. The best you can do is get another pharma company to hire even better lawyers to quash unjustified patents.

Thank you for that information. As I don’t know them or the amount of money they could potentially make from it, reading the conflict of interest initially made me think it was more significant than it actually is. So knowing that this it doesn’t discredit the study is good news.

Although, speaking for myself as someone with the disease, having someone close to you affected can potentially introduce some bias when interpreting subjective data (specifically when unblinded), or at least create an emotional conflict of interest.

 

[Utsikt]

Thank you for that information. As I don’t know them or the amount of money they could potentially make from it, reading the conflict of interest initially made me think it was more significant than it actually is. So knowing that this it doesn’t discredit the study is good news.

Although, speaking for myself as someone with the disease, having someone close to you affected can potentially introduce some bias when interpreting subjective data (specifically when unblinded), or at least create an emotional conflict of interest.

Bias will always be an issue when humans are involved. If it isn’t personal, it’s monetary, self-esteem, etc. Which is why they are doing blinded trials and being very thorough. They know that if they want to actually help, they need to be right, not just think they are right.

 

[DiBelloBr]

I haven't seen any kind of a timeframe for the ixatuximab study, afaik there isnt a protocol or anything anywhere yet.

There isn’t one so far. I think the question Venicequeenf asked me was based on an announcement by Dr. Carmen Scheibenbogen at Fatigatio 2025, saying that a study with an anti-CD38 antibody in cooperation with Sanofi is planned.

It would be good if it finished before or at the same time as dara, esp if both were positive. It would provide an added degree of confidence for off label prescription and phase 3.

Hope so!

 

[DiBelloBr]

Bias will always be an issue when humans are involved. If it isn’t personal, it’s monetary, self-esteem, etc. Which is why they are doing blinded trials and being very thorough. They know that if they want to actually help, they need to be right, not just think they are right.

Of course. It’s much better to be motivated by something personal like this than by money or greed, for the reasons you mentioned.