Should advocates be trying now to get a US rituximab trial started?

[Jonathan Edwards]

Is that why researchers take out a patent on an already approved medicine? To prevent that manufacturer from extending the patent due to new usage? I had wondered.

It probably does not happen that often but it may increasingly occur. I tried to get UCL to get a patent for use of rituximab in RA but the college patent people were completely useless. I would have been unlikely to get it anyway since the company would have fought it with huge legal resources. In the end nobody has a patent - which is what I would have preferred anyway. You can get new patents for any new ideas relating to a drug - new diseases to use it on or new ways of packaging it or giving it or combinations with other things or all sorts. You only get the patent if the idea is convincingly novel though.

 

[A.B.]

What consequences does Fluge and Mella's patent on Rituximab for the treatment of CFS have?

Do they stand to profit personally from positive results?

I read that a Norwegian government agency asked them to file this patent.

 

[Jonathan Edwards]

What consequences does Fluge and Mella's patent on Rituximab for the treatment of CFS have?

Do they stand to profit personally from positive results?

I read that a Norwegian government agency asked them to file this patent.

I think it was the Hospital research policy to do this so it was not their decision as such. They may profit from a positive result but that does not worry me. They have been so obsessive about methodology and have made sure the phase 3 is multicentre and blinded that I don't see any worry about conflict of interest.

 

[BurnA]

I am fairly sure Genentech are not keen on use of their B cell drugs for disease other than cancer because they make good business out of cancer and nobody worries too much about serious side effects in cancer......And they wouldn't get a patent since Fluge and Mella invented the treatment, just as I invented the use in RA and at least in Europe the patent was quashed.

My experience of big pharma is that the like money, and more patients means more money.

How about Genmab and Ofatumumab.... would it be worth their while to pursue a trial ?

 

[Jonathan Edwards]

My experience of big pharma is that the like money, and more patients means more money.

How about Genmab and Ofatumumab.... would it be worth their while to pursue a trial ?

Drug companies only make money if the physicians want to prescribe in the USA. The rest of the world market does not generate the profits. Physicians have had reasons not to want to prescribe rituximab in RA in the USA so the drug has not been pushed there. I suspect that the drug companies will hang fire in ME/CFS because not that many physicians will indicate they would want to use it - in addition to the side effects issues mentioned previously. There is also the problem that drug company designed trials are often badly designed and come up with no answer for that reason. A company trial with a false negative result would be worse than useless. That is what happened in lupus and it has been a big problem.

 

[leokitten]

Apologies to everyone if I didn't post this before, I should've it's important information.

During the CFSAC meeting I talked with Vicky Whitmore about NINDS NeuroNEXT funding an ME/CFS rituximab trial similar to what they are running for myasthenia gravis. We both agreed an ME/CFS rituximab trial would fit well at NeuroNEXT and that the evidence base is there to support funding it. She told me the only additional requirement is that the trial must include a neurological or cognitive study.

I've written all of these details in a letter to Drs. Klimas, Kogelnik and Levine urging them to submit a proposal. Supposedly Nancy was to meet with Vicky Whitmore after CFSAC, possibly to discuss something like this. I believe this is the best opportunity we will have to get a rituximab trial going here in the U.S.

 

[Sasha]

Well done, @leokitten!

 

[Scarecrow]

Apologies to everyone if I didn't post this before, I should've it's important information.

Slight memory lapse?

This is great news and I love the cognitive component. That would really complement the substudies in the Norwegian Phase III. I don't have the best link for full information on those but there are some details here.

 

[A.B.]

Apologies to everyone if I didn't post this before, I should've it's important information.

During the CFSAC meeting I talked with Vicky Whitmore about NINDS NeuroNEXT funding an ME/CFS rituximab trial similar to what they are running for myasthenia gravis. We both agreed an ME/CFS rituximab trial would fit well at NeuroNEXT and that the evidence base is there to support funding it. She told me the only additional requirement is that the trial must include a neurological or cognitive study.

That requirement sounds like an objective outcome that would be good to have anyway.

 

[BurnA]

Drug companies only make money if the physicians want to prescribe in the USA. The rest of the world market does not generate the profits.

I dont feel at all comfortable to disagree with what you say but I would lke to suggest Wyeth / Pfizer made a buck or two from rest of world Enbrel sales. Large patient population granted. Anyway....

A company trial with a false negative result would be worse than useless. That is what happened in lupus and it has been a big problem.

I agree. I also notice that for just about any new immune system related drug there seems to be ongoing or completed clinical trials for RA, MS and Lupus. It seems like it is de rigeur if you have a new mab that might work somehow or other.
Do you see ME being added to this list soon ? I'm not at all saying this is a good thing, it just seems to be the way things are going, more like a try it and see approach, in case they get lucky, is how it appears to me.

 

[Jonathan Edwards]

I dont feel at all comfortable to disagree with what you say but I would lke to suggest Wyeth / Pfizer made a buck or two from rest of world Enbrel sales. Large patient population granted. Anyway....



I agree. I also notice that for just about any new immune system related drug there seems to be ongoing or completed clinical trials for RA, MS and Lupus. It seems like it is de rigeur if you have a new mab that might work somehow or other.
Do you see ME being added to this list soon ? I'm not at all saying this is a good thing, it just seems to be the way things are going, more like a try it and see approach, in case they get lucky, is how it appears to me.

I am not sure ME will be added soon. Interestingly, if the Norwegain phase 33 comes out positive this will be the first disease where B cells are implicated before anyone has any other reason to try immune modulation. I suspect further work in ME will tend to stick to B cell strategies. Enbrel does not seem to be effective, although only pilot studies have been done.

 

[BurnA]

I am not sure ME will be added soon. Interestingly, if the Norwegain phase 33 comes out positive this will be the first disease where B cells are implicated before anyone has any other reason to try immune modulation. I suspect further work in ME will tend to stick to B cell strategies.

I realise i am asking some impossible questions but would you estimate the response rate to increase with new B cell strategies or just become more efficient for existing responders?

 

[Jonathan Edwards]

I realise i am asking some impossible questions but would you estimate the response rate to increase with new B cell strategies or just become more efficient for existing responders?

If they work it is likely to be a bit of both.

 

[Nielk]

Apologies to everyone if I didn't post this before, I should've it's important information.

During the CFSAC meeting I talked with Vicky Whitmore about NINDS NeuroNEXT funding an ME/CFS rituximab trial similar to what they are running for myasthenia gravis. We both agreed an ME/CFS rituximab trial would fit well at NeuroNEXT and that the evidence base is there to support funding it. She told me the only additional requirement is that the trial must include a neurological or cognitive study.

I've written all of these details in a letter to Drs. Klimas, Kogelnik and Levine urging them to submit a proposal. Supposedly Nancy was to meet with Vicky Whitmore after CFSAC, possibly to discuss something like this. I believe this is the best opportunity we will have to get a rituximab trial going here in the U.S.

Thank you! Is there anything that patients or advocates can do in support of this to push it along?

 

[leokitten]

Thank you! Is there anything that patients or advocates can do in support of this to push it along?

Not exactly sure what would help at this stage. Let's see what response I get, I mentioned in the letter that Drs. Klimas and Kogelnik would be best suited as PIs for the trial and NeuroNEXT proposal since their clinics have the most experience with rituximab here in the U.S. and that in a multicenter trial they can bring in all the major clinics such as Dr. Levine et al

 

[Nielk]

I didn't realize that Klimas had experience with Rituximab as well.

 

[jimells]

I tried to get UCL to get a patent for use of rituximab in RA but the college patent people were completely useless. I would have been unlikely to get it anyway since the company would have fought it with huge legal resources.

How do researchers benefit financially from these new-use patents? Do the drug manufacturers have to pay royalties based on an estimate of how much is sold to treat the specific illness?

 

[Jonathan Edwards]

How do researchers benefit financially from these new-use patents? Do the drug manufacturers have to pay royalties based on an estimate of how much is sold to treat the specific illness?

I guess so. I don't know the details. Maini I believe has a patent on usage of infliximab plus methotrexate for RA, but probably negotiated together with the company. The Norwegians are in an unusual position.

 

[BurnA]

I am not sure ME will be added soon. Interestingly, if the Norwegain phase 33 comes out positive this will be the first disease where B cells are implicated before anyone has any other reason to try immune modulation. I suspect further work in ME will tend to stick to B cell strategies. Enbrel does not seem to be effective, although only pilot studies have been done.

Do you think there are potentially other drugs on the market now that would be worth trialling for me/cfs ?

 

[Jonathan Edwards]

Do you think there are potentially other drugs on the market now that would be worth trialling for me/cfs ?

Lots of things have been tried and there may be others worth trying. The importance of rituximab is that it brings a theory with it - a B cell theory. Most other drugs have a range of different effects so it is harder to know how they are working and how to make use of that.